Vanderbilt University Institutional Review Board Informed ...The MRI will take place at the Vanderbilt Institute of Imaging Science Building. DEXA Scan Visit (45 minutes to 2 hours)-

Vanderbilt University Institutional Review Board Informed Consent Document for Research

Principal Investigator: Jeffry S. Nyman, PhD Revision Date: 5/31/2018 Study Title: New Tools for Assessing Fracture Risk Institution/Hospital: VUMC

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This informed consent applies to healthy volunteers Name of participant: _________________________________________________________ Age: ___________ The following is given to you to tell you about this research study. Please read this form with care and ask any questions you may have about this study. Your questions will be answered. Also, you will be given a copy of this consent form. You do not have to be in this research study. You can stop being in this study at any time. If we learn something new that may affect the risks or benefits of this study, you will be told so that you can decide whether or not you still want to be in this study. 1. What is the purpose of this study?

You are being asked to take part in this research study because we would like to compare the bone material properties in your forearm to the bone material properties of patients who have had a wrist fracture. This study is looking at new ways to predict a patient’s fracture risk. Your participation in this study will include an MRI (Magnetic Resonance Imaging) scan of one of your arms and a DEXA (Dual X-ray Absorptiometry) scan of the same arm, spine, and hips. An MRI scan uses strong magnetic fields and radiowaves to form images of your body. The MRI scan will be able to tell us how much bound water and pore water you have located in your arm bones for this study. A DEXA scan is used to determine bone mineral density. The DEXA scan of your arm, spine, and hips will be used in this study to determine your T-score, which is a metric used by doctors to help ascertain whether a patient has osteoporosis.

2. What will happen and how long will you be in the study?

Enrollment Visit (15-30 minutes)

Your enrollment visit will take place at Vanderbilt Orthopaedic Institute. You will be asked to fill out one survey about your ability to perform certain daily activities. You will also be set up to have an MRI and a DEXA scan. These scans may be on the same day. MRI Visit (1 to 1 ½ hours)- You will undergo an MRI of one of your arms. The MRI will take place at the Vanderbilt Institute of Imaging Science Building. DEXA Scan Visit (45 minutes to 2 hours)- You will undergo a DEXA scan of the same arm that was scanned by the MRI, your spine, and your hips. This DEXA scan will tell us your bone mineral density. The DEXA scan will take place at the Vanderbilt Clinical Research Center. If you are a female of childbearing potential, a blood sample will be collected for pregnancy testing prior to your DEXA scan (takes up to 1 hour for test results). If you are found to be pregnant, you will not be allowed to take part in this study. We will try to set up all of your study visits on one day, if possible.

3. Costs to you if you take part in this study:

There is no cost to you for taking part in this study. 4. Side effects and risks that you can expect if you take part in this study:

Common (>10%), uncommon (<10%) or rare (<1%)

Date of IRB Approval: 06/11/2018Date of Expiration: 05/23/2019



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Radiation Risk from DEXA Scan (Rare) You will undergo a DEXA scan which will slightly increase your radiation exposure. This research study involves exposure to radiation from 1 DEXA scan of your arm, spine, and hips. This radiation exposure is not necessary for your medical care and is for research purposes only. The total amount of radiation you will receive by participating in this study is equal to your body receiving 47 days of radiation from your natural surroundings.

Risks from MRI Scan (Rare) You will undergo an MRI scan for this study. MRIs do not use ionizing radiation so there are no harmful side-effects associated with temporary exposure to the strong magnetic field using by MRI scanners. The known risks of MRIs include:

objects brought into the room may be pulled toward the magnet (this risk will be reduced by standard operating procedures of MRI facilities)

a person that has an implanted metal or medical device may experience abnormal torques or fail to function properly (please notify the research coordinator if this applies to you)

a risk of tissue heating if there is an excessive power due to electromagnetic waves a risk of peripheral nerve stimulation subjects may experience a claustrophobic reaction when in the magnet (please notify the research

coordinator if this applies to you) there are loud banging noises with MRIs that may make you uncomfortable

Breach of Confidentiality (Rare) There is a rare chance that the confidentiality of the data we collect about you may be breached by taking part in this study. To lower this risk, all study documents will be kept in a secure location where only research staff will have access to them. All data that is recorded in an online Vanderbilt database will be password-protected, and will only be accessible by research personnel. Inconvenience The time and travel to your study visit(s) may be inconvenient for you. We will make our best effort to schedule all of your study visits on one day.

5. Risks that are not known:

If we discover an unknown risk to this study not listed in Item# 4 we will let you know about it.

6. Payment in case you are injured because of this research study:

If it is determined by Vanderbilt and the Investigator that an injury occurred as a direct result of the tests or treatments that are done for research, then you and/or your insurance will not have to pay for the cost of immediate medical care provided at Vanderbilt to treat the injury. There are no plans for Vanderbilt to pay for the costs of any additional care. There are no plans for Vanderbilt to give you money for the injury.

7. Good effects that might result from this study:

a) The benefits to science and humankind that might result from this study: This study is intended to determine if two new, non-x-ray techniques can tell the difference between bone quality in healthy volunteers, patients with healthy bone that have had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. This




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study may lead to the ability to determine new techniques to predict fracture risk, determine how drug therapies affect bone, and determine if these new techniques to determine bone quality are useful in surgery. b) The benefits you might get from being in this study: There is no direct benefit to you by participating in this study. You may receive a certain psychological reward knowing that you are contributing to increased medical knowledge that may help improve anti-fracture therapies in future patient populations.

8. Other treatments you could get if you decide not to be in this study:

Not applicable.

9. Payments for your time spent taking part in this study or expenses:

You will receive a check in the mail for $50 following completion of your DEXA visit and a check in the mail for $50 following completion of your MRI visit. This is reimbursement for your time and travel.

10. Reasons why the study doctor may take you out of this study:

You may be taken out of this study if it is determined that you no longer meet inclusion criteria. You may also be removed from the study if you are unable to follow study guidelines, like participating in the MRI and DEXA scan visits. If you are taken out of this study you will be told why.

11. What will happen if you decide to stop being in this study?

If you decide to stop being part of the study, you should tell the research investigator or research coordinator.

12. Who to call for any questions or in case you are injured:

If you should have any questions about this research study or if you feel you have been hurt by being a part of this study, please feel free to contact Dr. Jeff Nyman, Dr. Donald Lee, or Julie Daniels at 615-322-4506.

For additional information about giving consent or your rights as a person in this study, to discuss problems, concerns, and questions, or to offer input, please feel free to call the Vanderbilt University Institutional Review Board Office at (615) 322-2918 or toll free at (866) 224-8273.

13. Clinical Trials Registry.

A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

14. Confidentiality:

During this study every attempt will be made to keep your protected health information (PHI) private. To reduce the risk of a breach of confidentiality, all study data will be maintained in a password-protected Vanderbilt Redcap database. A Vanderbilt Redcap database is a secure, web-based application for building and managing online databases. The data obtained and stored in this database will only be accessible by research personnel. All Redcap data will be de-identified prior to statistical analysis. Any physical study forms (ex. consent documents, screening forms, surveys) will be kept in a locked cabinet in the Vanderbilt Hand & Upper Extremity Center




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Administrative Offices for 6 years following completion of the study at which time they will be disposed of in a shred-it confidentiality bin provided by VUMC. Vanderbilt may share your information, without identifiers, to others or use it for other research projects not listed in this form. Vanderbilt, Dr. Nyman and his staff will comply with any and all laws regarding the privacy of such information. There are no plans to pay you for the use or transfer of this de-identified information. This study may have some support from the National Institutes of Health (NIH). If so, your study information is protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out your information even if requested using legal means.

It does not protect information that we have to report by law, such as child abuse or some infectious diseases. The Certificate does not prevent us from disclosing your information if we learn of possible harm to yourself or others, or if you need medical help.

Disclosures that you consent to in this document are not protected. This includes putting research data in the medical record or sharing research data for this study or future research. Disclosures that you make yourself are also not protected.

15. Authorization to Use/Disclose Protected Health Information

All efforts, within reason, will be made to keep your protected health information (PHI) private. PHI is your health information that is, or has been gathered or kept by Vanderbilt as a result of your healthcare. This includes data gathered for research studies that can be traced back to you. Using or sharing (“disclosure”) such data must follow federal privacy rules. By signing the consent for this study, you are agreeing (“authorization”) to the uses and likely sharing of your PHI. If you decide to be in this research study, you are also agreeing to let the study team use and share your PHI as described below. As part of the study, Dr. Nyman and his study team may share the results of your study, as well as parts of your medical record, to the groups named below. These groups may include people from the: Active Life Scientific, Inc, Federal Government Office for Human Research Protections, the Vanderbilt University Institutional Review Board, and the National Institutes of Health. Federal privacy rules may not apply to these groups; they have their own rules and codes to assure that all efforts, within reason, will be made to keep your PHI private. The study results will be kept in your research record for at least six years after the study is finished. At that time, the research data that has not been put in your medical record will be kept for an unknown length of time. Any research data that has been put into your medical record will be kept for an unknown length of time. Unless told otherwise, your consent to use or share your PHI does not expire. If you change your mind, we ask that you contact Dr. Nyman in writing and let him know that you withdraw your consent. His mailing address is 1215 21st Avenue South, Ste. 3200, Nashville, TN, 37232-8828. At that time, we will stop getting any more data about you. But, the health data we stored before you withdrew your consent may still be used for reporting and research quality.

If you decide not to take part in this research study, it will not affect your treatment, payment or enrollment

in any health plans or affect your ability to get benefits. You will get a copy of this form after it is signed.




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STATEMENT BY PERSON AGREEING TO BE IN THIS STUDY I have read this consent form and the research study has been explained to me verbally. All my questions

have been answered, and I freely and voluntarily choose to take part in this study. Date Signature of volunteer

Consent obtained by: Date Signature _______________ Printed Name and Title Time




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This informed consent applies to adults with a distal radius fracture being treated nonoperatively (with DEXA) Name of participant: _________________________________________________________ Age: ___________ The following is given to you to tell you about this research study. Please read this form with care and ask any questions you may have about this study. Your questions will be answered. Also, you will be given a copy of this consent form. You do not have to be in this research study. You may choose not to be in this study and get other treatments without changing your healthcare, services or other rights. You can stop being in this study at any time. If we learn something new that may affect the risks or benefits of this study, you will be told so that you can decide whether or not you still want to be in this study. Your medical record will contain a note saying you are in a research study. Anyone you authorize to receive your medical record will also get this note. 1. What is the purpose of this study?

You are being asked to take part in this research study because you have a wrist (distal radius) fracture that requires non-surgical intervention. This study is looking at new ways and devices that may predict a patient’s fracture risk. We would like to determine the difference in bone material between healthy volunteers, patients with healthy bone that have had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. Your participation in this study will include a DEXA (Dual X-ray Absorptiometry) scan of your spine, hips, and non-fractured wrist. A DEXA scan is used to determine bone mineral density. The DEXA scan of your arm, spine, and hips will be used in this study to determine your T-score, which is a metric used by doctors to help ascertain whether a patient has osteoporosis.

2. What will happen and how long will you be in the study? As part of your routine care, you will have your wrist fracture placed in a cast. Your follow-up schedule is determined by your doctor, and based on what type of treatment you receive as part of your routine clinical care.

Enrollment Visit/Before Treatment (30 minutes)

You will be asked to complete two surveys about yourself and your symptoms today You will be scheduled for a research DEXA scan

DEXA Scan Visit (45 minutes to 2 hours)- You will undergo a DEXA scan of your spine, hips, and non-fractured wrist. This DEXA scan will tell us your bone mineral density. The DEXA scan will take place at the Vanderbilt Clinical Research Center. If you are a female of childbearing potential, a blood sample will be collected for pregnancy testing prior to your DEXA scan (takes up to 1 hour for test results). If you are found to be pregnant, you will not be allowed to take part in this study. 3 Weeks After Treatment (30 minutes to 1 hour)

You will be asked to complete two surveys about yourself and your symptoms today 6 Weeks After Treatment (30 minutes to 1 hour)

You will be asked to complete two surveys about yourself and your symptoms today Your doctor or a research coordinator will take measurements of your wrist

12 Weeks After Treatment (30 minutes to 1 hour)






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If you agree to take part in this research study, you and/or your insurance will not have to pay for the tests and treatments that are being done only for research.

However, you are still responsible for paying for the usual care you would normally receive for the treatment of your illness. This includes treatments and tests you would need even if you were not in this study. These costs will be billed to you and/or your insurance.

You have the right to ask what it may cost you to take part in this study. If you would like assistance, financial counseling is available through the Vanderbilt Financial Assistance Program. The study staff can help you contact this program. You have the right to contact your insurance company to discuss the costs of your routine care (non-research) further before choosing to be in the study. You may choose not to be in this study if your insurance does not pay for your routine care (non-research) costs and your doctor will discuss other treatment plans with you.

4. Side effects and risks that you can expect if you take part in this study:


Radiation Risk from DEXA Scan (Rare) You will undergo a DEXA scan, which will slightly increase your radiation exposure. This research study involves exposure to radiation from 1DEXA scan of your arm, spine, and hips. This radiation exposure is not necessary for your medical care and is for research purposes only. The total amount of radiation you will receive by participating in this study is equal to your body receiving 47 days of radiation from your natural surroundings. Breach of Confidentiality (Rare) There is a rare chance that the confidentiality of the data we collect about you may be breached by taking part in this study. To lower this risk, all study documents will be kept in a secure location where only research staff will have access to them. All data that is recorded in an online Vanderbilt database will be password-protected, and will only be accessible by research personnel. Inconvenience The time and travel to your study visit(s) may be inconvenient for you. We will make our best effort to schedule the DEXA visit in combination with a routine clinic visit.






a) The benefits to science and humankind that might result from this study: This study is intended to determine if two new, non-X-ray techniques can tell the difference in bone quality among healthy volunteers, patients with healthy bone that have had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. This




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study may lead to the ability to advance new techniques to predict fracture risk, determine how drug therapies affect bone, and assess whether these new techniques to determine bone quality are useful in surgery. b) The benefits you might get from being in this study: There is no direct benefit to you by participating in this study. You may receive a certain psychological reward knowing that you are contributing to increased medical knowledge that may help improve anti-fracture therapies in future patient populations.


You can receive the same routine treatment without taking part in this study.


You will receive a check in the mail for $50 following completion of your DEXA visit. This is reimbursement for your time and travel.

10. Reasons why the study doctor may take you out of this study: You may be taken out of this study if it is determined that you no longer meet inclusion criteria. You may also be removed from the study if you are unable to follow study guidelines, like participating in the DEXA scan visit. If you are taken out of this study you will be told why.









During this study every attempt will be made to keep your protected health information (PHI) private. To reduce the risk of a breach of confidentiality, most study data will be maintained in a password-protected Vanderbilt Redcap database. A Vanderbilt Redcap database is a secure, web-based application for building and managing online databases. The data obtained and stored in this database will only be accessible by research personnel. All Redcap data will be de-identified prior to statistical analysis. Any physical study forms (ex. consent documents, screening forms, surveys) will be kept in a locked cabinet in the Vanderbilt Hand & Upper Extremity Center




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Administrative Offices for 6 years following completion of the study at which time they will be disposed of in a shred-it confidentiality bin provided by VUMC. Vanderbilt may share your information, without identifiers, to others or use it for other research projects not listed in this form. Vanderbilt, Dr. Nyman and his staff will comply with any and all laws regarding the privacy of such information. There are no plans to pay you for the use or transfer of this de-identified information. This study may have some support from the National Institutes of Health (NIH). If so, your study information is protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out your information even if requested using legal means.










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have been answered, and I freely and voluntarily choose to take part in this study. Date Signature of patient/volunteer





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This informed consent applies to adults with a distal radius fracture being treated nonoperatively (with MRI and DEXA) Name of participant: _________________________________________________________ Age: ___________ The following is given to you to tell you about this research study. Please read this form with care and ask any questions you may have about this study. Your questions will be answered. Also, you will be given a copy of this consent form. You do not have to be in this research study. You may choose not to be in this study and get other treatments without changing your healthcare, services or other rights. You can stop being in this study at any time. If we learn something new that may affect the risks or benefits of this study, you will be told so that you can decide whether or not you still want to be in this study. Your medical record will contain a note saying you are in a research study. Anyone you authorize to receive your medical record will also get this note. 1. What is the purpose of this study?

You are being asked to take part in this research study because you have a wrist (distal radius) fracture that requires non-surgical intervention. This study is looking at new ways and devices that may predict a patient’s fracture risk. We would like to determine the difference in bone material between healthy volunteers, patients with healthy bone that have had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. Your participation in this study will include an MRI (Magnetic Resonance Imaging) scan of your non-fractured wrist and a DEXA (Dual X-ray Absorptiometry) scan of your spine, hips, and non-fractured wrist. An MRI scan uses strong magnetic fields and radiowaves to form images of your body. The MRI scan will be able to tell us how much bound water and pore water you have located in your arm bones. A DEXA scan is used to determine bone mineral density. The DEXA scan of your arm, spine, and hips will be used in this study to determine your T-score, which is a metric used by doctors to help ascertain whether a patient has osteoporosis.

2. What will happen and how long will you be in the study? As part of your routine care, you will have your wrist fracture placed in a cast. Your follow-up schedule is determined by your doctor, and based on what type of treatment you receive as part of your routine clinical care.

Enrollment Visit/Before Treatment (30 minutes)

You will be asked to complete two surveys about yourself and your symptoms today You will be scheduled for a research MRI scan and a research DEXA scan

MRI Visit (1 to 1 ½ hours)- You will undergo an MRI of your non-fractured wrist. The MRI will take place at the Vanderbilt Institute of Imaging Science Building. DEXA Scan Visit (45 minutes to 2 hours)- You will undergo a DEXA scan of your spine, hips, and non-fractured wrist. This DEXA scan will tell us your bone mineral density. The DEXA scan will take place at the Vanderbilt Clinical Research Center. If you are a female of childbearing potential, a blood sample will be collected for pregnancy testing prior to your DEXA scan (takes up to 1 hour for test results). If you are found to be pregnant, you will not be allowed to take part in this study. 3 Weeks After Treatment (30 minutes to 1 hour)

You will be asked to complete two surveys about yourself and your symptoms today 6 Weeks After Treatment (30 minutes to 1 hour)





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12 Weeks After Treatment (30 minutes to 1 hour) You will be asked to complete two surveys about yourself and your symptoms today Your doctor or a research coordinator will take measurements of your wrist







Radiation Risk from DEXA Scan (Rare) You will undergo a DEXA scan, which will slightly increase your radiation exposure. This research study involves exposure to radiation from 1DEXA scan of your arm, spine, and hips. This radiation exposure is not necessary for your medical care and is for research purposes only. The total amount of radiation you will receive by participating in this study is equal to your body receiving 47 days of radiation from your natural surroundings.



a person that has an implanted metal or medical device may experience abnormal torques or fail to function properly (please notify the research coordinator if this applies to you). Note that the wrist with the plating system will NOT be placed inside the magnet.



Breach of Confidentiality (Rare) There is a rare chance that the confidentiality of the data we collect about you may be breached by taking part in this study. To lower this risk, all study documents will be kept in a secure location where only research staff will have access to them. All data that is recorded in an online Vanderbilt database will be password-protected, and will only be accessible by research personnel. Inconvenience




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The time and travel to your study visit(s) may be inconvenient for you. We will make our best effort to schedule the MRI and DEXA visits on one day, possibly in combination with a routine clinic visit.






a) The benefits to science and humankind that might result from this study: This study is intended to determine if two new, non-X-ray techniques can tell the difference in bone quality among healthy volunteers, patients with healthy bone that have had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. This study may lead to the ability to advance new techniques to predict fracture risk, determine how drug therapies affect bone, and assess whether these new techniques to determine bone quality are useful in surgery. b) The benefits you might get from being in this study: There is no direct benefit to you by participating in this study. You may receive a certain psychological reward knowing that you are contributing to increased medical knowledge that may help improve anti-fracture therapies in future patient populations.





10. Reasons why the study doctor may take you out of this study: You may be taken out of this study if it is determined that you no longer meet inclusion criteria. You may also be removed from the study if you are unable to follow study guidelines, like participating in the MRI and DEXA scan visits. If you are taken out of this study you will be told why.








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During this study every attempt will be made to keep your protected health information (PHI) private. To reduce the risk of a breach of confidentiality, most study data will be maintained in a password-protected Vanderbilt Redcap database. A Vanderbilt Redcap database is a secure, web-based application for building and managing online databases. The data obtained and stored in this database will only be accessible by research personnel. All Redcap data will be de-identified prior to statistical analysis. Any physical study forms (ex. consent documents, screening forms, surveys) will be kept in a locked cabinet in the Vanderbilt Hand & Upper Extremity Center Administrative Offices for 6 years following completion of the study at which time they will be disposed of in a shred-it confidentiality bin provided by VUMC. Vanderbilt may share your information, without identifiers, to others or use it for other research projects not listed in this form. Vanderbilt, Dr. Nyman and his staff will comply with any and all laws regarding the privacy of such information. There are no plans to pay you for the use or transfer of this de-identified information. This study may have some support from the National Institutes of Health (NIH). If so, your study information is protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out your information even if requested using legal means.




All efforts, within reason, will be made to keep your protected health information (PHI) private. PHI is your health information that is, or has been gathered or kept by Vanderbilt as a result of your healthcare. This includes data gathered for research studies that can be traced back to you. Using or sharing (“disclosure”) such data must follow federal privacy rules. By signing the consent for this study, you are agreeing (“authorization”) to the uses and likely sharing of your PHI. If you decide to be in this research study, you are also agreeing to let the study team use and share your PHI as described below. As part of the study, Dr. Nyman and his study team may share the results of your study, as well as parts of your medical record, to the groups named below. These groups may include people from the: Active Life Scientific, Inc, Federal Government Office for Human Research Protections, the Vanderbilt University Institutional Review Board,




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and the National Institutes of Health. Federal privacy rules may not apply to these groups; they have their own rules and codes to assure that all efforts, within reason, will be made to keep your PHI private. The study results will be kept in your research record for at least six years after the study is finished. At that time, the research data that has not been put in your medical record will be kept for an unknown length of time. Any research data that has been put into your medical record will be kept for an unknown length of time. Unless told otherwise, your consent to use or share your PHI does not expire. If you change your mind, we ask that you contact Dr. Nyman in writing and let him know that you withdraw your consent. His mailing address is 1215 21st Avenue South, Ste. 3200, Nashville, TN, 37232-8828. At that time, we will stop getting any more data about you. But, the health data we stored before you withdrew your consent may still be used for reporting and research quality.









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This informed consent applies to adults with a distal radius fracture being treated operatively (with DEXA) Name of participant: _________________________________________________________ Age: ___________ The following is given to you to tell you about this research study. Please read this form with care and ask any questions you may have about this study. Your questions will be answered. Also, you will be given a copy of this consent form. You do not have to be in this research study. You may choose not to be in this study and get other treatments without changing your healthcare, services or other rights. You can stop being in this study at any time. If we learn something new that may affect the risks or benefits of this study, you will be told so that you can decide whether or not you still want to be in this study. Your medical record will contain a note saying you are in a research study. Anyone you authorize to receive your medical record will also get this note. 1. What is the purpose of this study?

You are being asked to take part in this research study because you have a wrist (distal radius) fracture that requires surgical intervention. This study is looking at new ways and devices that may predict a patient’s fracture risk. We would like to determine the difference in bone material between healthy volunteers, patients with healthy bone that have had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. This study will involve a device called an OsteoProbe. It is a hand-held device that is applied to bone and tests bone material strength (or the ability of bone to resist indentation). Your participation in this study will include a DEXA (Dual X-ray Absorptiometry) scan of your spine, hips, and non-fractured wrist. A DEXA scan is used to determine bone mineral density. The DEXA scan of your arm, spine, and hips will be used in this study to determine your T-score, which is a metric used by doctors to help ascertain whether a patient has osteoporosis. In addition to the DEXA scan, your distal radius bone will be indented with the OsteoProbe instrument during surgery to test your bone material strength. The OsteoProbe instrument will be applied to your bone after you have been sedated, and the incision to your arm is made. It will also occur before the surgeon repairs your distal radius fracture using a plating system. Your surgeon will apply the instrument to your distal radius bone at up to 15 different locations about 2 mm apart (less than a tenth of an inch apart). Each indentation is smaller than the screws used to secure the plating system. Once all OsteoProbe measurements have been obtained the surgeon will continue on with routine surgery.

2. What will happen and how long will you be in the study? As part of your routine care, you will have surgery to repair your wrist fracture. Your follow-up schedule is determined by your doctor, and based on what type of treatment you receive as part of your routine clinical care.

Enrollment Visit/Before Surgery (30 minutes)

You will be asked to complete two surveys about yourself and your symptoms today You will be scheduled for a research DEXA scan

Surgery Visit (2 to 3 hours)

During your routine surgery, your surgeon will apply the OsteoProbe to your distal radius (wrist) bone at up to 15 different locations about 2 mm apart. The OsteoProbe will tell us your bone material strength.

DEXA Scan Visit (45 minutes to 2 hours)- You will undergo a DEXA scan of your spine, hips, and non-fractured wrist. This DEXA scan will tell us your bone mineral density. The DEXA scan will take place at the Vanderbilt Clinical Research Center. If you are a female of




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childbearing potential, a blood sample will be collected for pregnancy testing prior to your DEXA scan (takes up to 1 hour for test results). If you are found to be pregnant, you will not be allowed to take part in this study. 3 Weeks After Surgery (30 minutes to 1 hour)

You will be asked to complete two surveys about yourself and your symptoms today 6 Weeks After Surgery (30 minutes to 1 hour)


12 Weeks After Surgery (30 minutes to 1 hour)








Infection Risk (Uncommon) As with any surgical procedure there is a slight risk of infection. To minimize this risk, the OsteoProbe tip that is used to indent your wrist bone will be sterilized prior to surgery. In addition, a sterilized sleeve will cover the other portions of the Osteoprobe machine. Radiation Risk from DEXA Scan (Rare) You will undergo a DEXA scan, which will slightly increase your radiation exposure. This research study involves exposure to radiation from 1DEXA scan of your arm, spine, and hips. This radiation exposure is not necessary for your medical care and is for research purposes only. The total amount of radiation you will receive by participating in this study is equal to your body receiving 47 days of radiation from your natural surroundings.

Breach of Confidentiality (Rare) There is a rare chance that the confidentiality of the data we collect about you may be breached by taking part in this study. To lower this risk, all study documents will be kept in a secure location where only research staff will have access to them. All data that is recorded in an online Vanderbilt database will be password-protected, and will only be accessible by research personnel. Inconvenience




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The time and travel to your study visit(s) may be inconvenient for you. We will make our best effort to schedule the DEXA visit in combination with a routine clinic visit.










You will receive a check for $50 following completion of your DEXA visit. This is reimbursement for your time and travel.

10. Reasons why the study doctor may take you out of this study: You may be taken out of this study if it is determined that you no longer meet inclusion criteria. You may also be removed from the study if you are unable to follow study guidelines, like participating in the DEXA scan visit. If you are taken out of this study you will be told why.








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During this study every attempt will be made to keep your protected health information (PHI) private. To reduce the risk of a breach of confidentiality, most study data will be maintained in a password-protected Vanderbilt Redcap database. A Vanderbilt Redcap database is a secure, web-based application for building and managing online databases. The data obtained and stored in this database will only be accessible by research personnel. All Redcap data will be de-identified prior to statistical analysis. All OsteoProbe measurements taken will be relayed from the OsteoProbe to a laptop which his connected to the instrument during the surgical case. The imported data will be displayed in an excel spreadsheet. This excel spreadsheet will be saved on a password-protected computer(s) held by research personnel. In addition, some of this data will be transferred to the Redcap study database and deleted from the excel file. Any physical study forms (ex. consent documents, screening forms, surveys) will be kept in a locked cabinet in the Vanderbilt Hand & Upper Extremity Center Administrative Offices for 6 years following completion of the study at which time they will be disposed of in a shred-it confidentiality bin provided by VUMC. Vanderbilt may share your information, without identifiers, to others or use it for other research projects not listed in this form. Vanderbilt, Dr. Nyman and his staff will comply with any and all laws regarding the privacy of such information. There are no plans to pay you for the use or transfer of this de-identified information. This study may have some support from the National Institutes of Health (NIH). If so, your study information is protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out your information even if requested using legal means.




All efforts, within reason, will be made to keep your protected health information (PHI) private. PHI is your health information that is, or has been gathered or kept by Vanderbilt as a result of your healthcare. This includes data gathered for research studies that can be traced back to you. Using or sharing (“disclosure”) such data must follow federal privacy rules. By signing the consent for this study, you are agreeing (“authorization”) to the uses and likely sharing of your PHI. If you decide to be in this research study, you are also agreeing to let the study team use and share your PHI as described below.




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As part of the study, Dr. Nyman and his study team may share the results of your study, as well as parts of your medical record, to the groups named below. These groups may include people from the: Active Life Scientific, Inc, Federal Government Office for Human Research Protections, the Vanderbilt University Institutional Review Board, and the National Institutes of Health. Federal privacy rules may not apply to these groups; they have their own rules and codes to assure that all efforts, within reason, will be made to keep your PHI private. The study results will be kept in your research record for at least six years after the study is finished. At that time, the research data that has not been put in your medical record will be kept for an unknown length of time. Any research data that has been put into your medical record will be kept for an unknown length of time. Unless told otherwise, your consent to use or share your PHI does not expire. If you change your mind, we ask that you contact Dr. Nyman in writing and let him know that you withdraw your consent. His mailing address is 1215 21st Avenue South, Ste. 3200, Nashville, TN, 37232-8828. At that time, we will stop getting any more data about you. But, the health data we stored before you withdrew your consent may still be used for reporting and research quality.









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This informed consent applies to adults with a distal radius fracture being treated operatively (with MRI and DEXA) Name of participant: _________________________________________________________ Age: ___________ The following is given to you to tell you about this research study. Please read this form with care and ask any questions you may have about this study. Your questions will be answered. Also, you will be given a copy of this consent form. You do not have to be in this research study. You may choose not to be in this study and get other treatments without changing your healthcare, services or other rights. You can stop being in this study at any time. If we learn something new that may affect the risks or benefits of this study, you will be told so that you can decide whether or not you still want to be in this study. Your medical record will contain a note saying you are in a research study. Anyone you authorize to receive your medical record will also get this note. 1. What is the purpose of this study?

You are being asked to take part in this research study because you have a wrist (distal radius) fracture that requires surgical intervention. This study is looking at new ways and devices that may predict a patient’s fracture risk. We would like to determine the difference in bone material between healthy volunteers, patients with healthy bone that have had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. This study will involve a device called an OsteoProbe. It is a hand-held device that is1 applied to bone and tests bone material strength (or the ability of bone to resist indentation). Your participation in this study will include an MRI (Magnetic Resonance Imaging) scan of your non-fractured wrist and a DEXA (Dual X-ray Absorptiometry) scan of your spine, hips, and non-fractured wrist. An MRI scan uses strong magnetic fields and radiowaves to form images of your body. The MRI scan will be able to tell us how much bound water and pore water you have located in your arm bones. A DEXA scan is used to determine bone mineral density. The DEXA scan of your arm, spine, and hips will be used in this study to determine your T-score, which is a metric used by doctors to help ascertain whether a patient has osteoporosis. In addition to the MRI and DEXA scan, your distal radius bone will be indented with the OsteoProbe instrument during surgery to test your bone material strength. The OsteoProbe instrument will be applied to your bone after you have been sedated, and the incision to your arm is made. It will also occur before the surgeon repairs your distal radius fracture using a plating system. Your surgeon will apply the instrument to your distal radius bone at up to 15 different locations about 2 mm apart (less than a tenth of an inch apart). Each indentation is smaller than the screws used to secure the plating system. Once all OsteoProbe measurements have been obtained the surgeon will continue on with routine surgery.

2. What will happen and how long will you be in the study? As part of your routine care, you will have surgery to repair your wrist fracture. Your follow-up schedule is determined by your doctor, and based on what type of treatment you receive as part of your routine clinical care.

Enrollment Visit/Before Surgery (30 minutes)

You will be asked to complete two surveys about yourself and your symptoms today You will be scheduled for a research MRI scan and a research DEXA scan

Surgery Visit (2 to 3 hours)

During your routine surgery, your surgeon will apply the OsteoProbe to your distal radius (wrist) bone at up to 15 different locations about 2 mm apart. The OsteoProbe will tell us your bone material strength.

MRI Visit (1 to 1 ½ hours)-




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You will undergo an MRI of your non-fractured wrist. The MRI will take place at the Vanderbilt Institute of Imaging Science Building. DEXA Scan Visit (45 minutes to 2 hours)- You will undergo a DEXA scan of your spine, hips, and non-fractured wrist. This DEXA scan will tell us your bone mineral density. The DEXA scan will take place at the Vanderbilt Clinical Research Center. If you are a female of childbearing potential, a blood sample will be collected for pregnancy testing prior to your DEXA scan (takes up to 1 hour for test results). If you are found to be pregnant, you will not be allowed to take part in this study. 3 Weeks After Surgery (30 minutes to 1 hour)

You will be asked to complete two surveys about yourself and your symptoms today 6 Weeks After Surgery (30 minutes to 1 hour)










Infection Risk (Uncommon) As with any surgical procedure there is a slight risk of infection. To minimize this risk, the OsteoProbe tip that is used to indent your wrist bone will be sterilized prior to surgery. In addition, a sterilized sleeve will cover the other portions of the Osteoprobe machine. Radiation Risk from DEXA Scan (Rare) You will undergo a DEXA scan, which will slightly increase your radiation exposure. This research study involves exposure to radiation from 1DEXA scan of your arm, spine, and hips. This radiation exposure is not necessary for your medical care and is for research purposes only. The total amount of radiation you will receive by participating in this study is equal to your body receiving 47 days of radiation from your natural surroundings.




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a person that has an implanted metal or medical device may experience abnormal torques or fail to function properly (please notify the research coordinator if this applies to you). Note that the wrist with the plating system will NOT be placed inside the magnet.



Breach of Confidentiality (Rare) There is a rare chance that the confidentiality of the data we collect about you may be breached by taking part in this study. To lower this risk, all study documents will be kept in a secure location where only research staff will have access to them. All data that is recorded in an online Vanderbilt database will be password-protected, and will only be accessible by research personnel. Inconvenience The time and travel to your study visit(s) may be inconvenient for you. We will make our best effort to schedule the MRI and DEXA visits on one day, possibly in combination with a routine clinic visit.










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10. Reasons why the study doctor may take you out of this study: You may be taken out of this study if it is determined that you no longer meet inclusion criteria. You may also be removed from the study if you are unable to follow study guidelines, like participating in the MRI and DEXA scan visits. If you are taken out of this study you will be told why.









During this study every attempt will be made to keep your protected health information (PHI) private. To reduce the risk of a breach of confidentiality, most study data will be maintained in a password-protected Vanderbilt Redcap database. A Vanderbilt Redcap database is a secure, web-based application for building and managing online databases. The data obtained and stored in this database will only be accessible by research personnel. All Redcap data will be de-identified prior to statistical analysis. All OsteoProbe measurements taken will be relayed from the OsteoProbe to a laptop which his connected to the instrument during the surgical case. The imported data will be displayed in an excel spreadsheet. This excel spreadsheet will be saved on a password-protected computer(s) held by research personnel. In addition, some of this data will be transferred to the Redcap study database and deleted from the excel file. Any physical study forms (ex. consent documents, screening forms, surveys) will be kept in a locked cabinet in the Vanderbilt Hand & Upper Extremity Center Administrative Offices for 6 years following completion of the study at which time they will be disposed of in a shred-it confidentiality bin provided by VUMC.




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Vanderbilt may share your information, without identifiers, to others or use it for other research projects not listed in this form. Vanderbilt, Dr. Nyman and his staff will comply with any and all laws regarding the privacy of such information. There are no plans to pay you for the use or transfer of this de-identified information. This study may have some support from the National Institutes of Health (NIH). If so, your study information is protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out your information even if requested using legal means.








have been answered, and I freely and voluntarily choose to take part in this study.




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Date Signature of patient/volunteer



05/31/2018 2:01pm projectredcap.org

ConfidentialPage 1 of 5

Consent Operative Fx W Mri

Principal Investigator: Jeffry S. Nyman, PhDStudy Title: New Tools for Assessing Fracture RiskInstitution/Hospital: VUMCVersion Date: 5/31/2018Name of Participant:

__________________________________(First Last)

Age of Participant:__________________________________

1.) What is the purpose of this study?You are being asked to take part in this research study because you have a wrist (distal radius) fracture that requiressurgical intervention. This study is looking at new ways and devices that may predict a patient's fracture risk. Wewould like to determine the difference in bone material between healthy volunteers, patients with healthy bone thathave had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. This study will involvea device called an OsteoProbe. It is a hand-held device that is applied to bone and tests bone material strength (orthe ability of bone to resist indentation).

Your participation in this study will include an MRI (Magnetic Resonance Imaging) scan of your non-fractured wristand a DEXA (Dual X-ray Absorptiometry) scan of your spine, hips, and non-fractured wrist. An MRI scan uses strongmagnetic fields and radiowaves to form images of your body. The MRI scan will be able to tell us how much boundwater and pore water you have located in your arm bones. A DEXA scan is used to determine bone mineral density. The DEXA scan of your arm, spine, and hips will be used in this study to determine your T-score, which is a metricused by doctors to help ascertain whether a patient has osteoporosis.

In addition to the MRI and DEXA scan, your distal radius bone will be indented with the OsteoProbe instrument duringsurgery to test your bone material strength. The OsteoProbe instrument will be applied to your bone after you havebeen sedated, and the incision to your arm is made. It will also occur before the surgeon repairs your distal radiusfracture using a plating system. Your surgeon will apply the instrument to your distal radius bone at up to 15different locations about 2 mm apart (less than a tenth of an inch apart). Each indentation is smaller than the screwsused to secure the plating system. Once all OsteoProbe measurements have been obtained the surgeon willcontinue on with routine surgery.

2.) What will happen and how long will you be in the study?As part of your routine care, you will have surgery to repair your wrist fracture. Your follow-up schedule isdetermined by your doctor, and based on what type of treatment you receive as part of your routine clinical care.

Enrollment Visit/Before Surgery (30 minutes)• You will be asked to complete two surveys about yourself and your symptoms today• You will be scheduled for a research MRI scan and a research DEXA scan

Surgery Visit (2 to 3 hours)• During your routine surgery, your surgeon will apply the OsteoProbe to your distal radius (wrist) bone at up to 15different locations about 2 mm apart. The OsteoProbe will tell us your bone material strength.

MRI Visit (1 to 1 ½ hours)- You will undergo an MRI of your non-fractured wrist. The MRI will take place at the Vanderbilt Institute of ImagingScience Building.

DEXA Scan Visit (45 minutes to 2 hours)- You will undergo a DEXA scan of your spine, hips, and non-fractured wrist. This DEXA scan will tell us your bonemineral density. The DEXA scan will take place at the Vanderbilt Clinical Research Center. If you are a female ofchildbearing potential, a blood sample will be collected for pregnancy testing prior to your DEXA scan (takes up to 1hour for test results). If you are found to be pregnant, you will not be allowed to take part in this study.

3 Weeks After Surgery (30 minutes to 1 hour)• You will be asked to complete two surveys about yourself and your symptoms today


https://projectredcap.org

danielj4

Highlight

6 Weeks After Surgery (30 minutes to 1 hour)• You will be asked to complete two surveys about yourself and your symptoms today• Your doctor or a research coordinator will take measurements of your wrist


3.) Costs to you if you take part in this study:If you agree to take part in this research study, you and/or your insurance will not have to pay for the tests andtreatments that are being done only for research.

However, you are still responsible for paying for the usual care you would normally receive for the treatment of yourillness. This includes treatments and tests you would need even if you were not in this study. These costs will bebilled to you and/or your insurance.

You have the right to ask what it may cost you to take part in this study. If you would like assistance, financialcounseling is available through the Vanderbilt Financial Assistance Program. The study staff can help you contactthis program. You have the right to contact your insurance company to discuss the costs of your routine care(non-research) further before choosing to be in the study. You may choose not to be in this study if your insurancedoes not pay for your routine care (non-research) costs and your doctor will discuss other treatment plans with you.

4.) Side effects and risks that you can expect if you take part in this study:Infection Risk (Uncommon)

As with any surgical procedure there is a slight risk of infection. To minimize this risk, the OsteoProbe tip that is usedto indent your wrist bone will be sterilized prior to surgery. In addition, a sterilized sleeve will cover the otherportions of the Osteoprobe machine.

Radiation Risk from DEXA Scan (Rare)

You will undergo a DEXA scan, which will slightly increase your radiation exposure. This research study involvesexposure to radiation from 1DEXA scan of your arm, spine, and hips. This radiation exposure is not necessary foryour medical care and is for research purposes only. The total amount of radiation you will receive by participating inthis study is equal to your body receiving 47 days of radiation from your natural surroundings.

Risks from MRI Scan (Rare)

You will undergo an MRI scan for this study. MRIs do not use ionizing radiation so there are no harmful side-effectsassociated with temporary exposure to the strong magnetic field using by MRI scanners. The known risks of MRIsinclude:• objects brought into the room may be pulled toward the magnet (this risk will be reduced by standard operatingprocedures of MRI facilities)• a person that has an implanted metal or medical device may experience abnormal torques or fail to functionproperly (please notify the research coordinator if this applies to you). Note that the wrist with the plating system willNOT be placed inside the magnet.• a risk of tissue heating if there is an excessive power due to electromagnetic waves• a risk of peripheral nerve stimulation • subjects may experience a claustrophobic reaction when in the magnet (please notify the research coordinator ifthis applies to you)• there are loud banging noises with MRIs that may make you uncomfortable

Breach of Confidentiality (Rare)

There is a rare chance that the confidentiality of the data we collect about you may be breached by taking part inthis study. To lower this risk, all study documents will be kept in a secure location where only research staff will haveaccess to them. All data that is recorded in an online Vanderbilt database will be password-protected, and will onlybe accessible by research personnel.

Inconvenience

The time and travel to your study visit(s) may be inconvenient for you. We will make our best effort to schedule theMRI and DEXA visits on one day, possibly in combination with a routine clinic visit. Date of IRB Approval: 06/11/2018

Date of Expiration: 05/23/2019



Additional Information:5.) Risks that are not known:


6.) Payment in case you are injured because of this research study:

If it is determined by Vanderbilt and the Investigator that an injury occurred as a direct result of the tests ortreatments that are done for research, then you and/or your insurance will not have to pay for the cost of immediatemedical care provided at Vanderbilt to treat the injury.

There are no plans for Vanderbilt to pay for the costs of any additional care. There are no plans for Vanderbilt to giveyou money for the injury.

7.) Good effects that might result from this study:

a) The benefits to science and humankind that might result from this study: This study is intended to determine iftwo new, non-X-ray techniques can tell the difference in bone quality among healthy volunteers, patients withhealthy bone that have had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. Thisstudy may lead to the ability to advance new techniques to predict fracture risk, determine how drug therapies affectbone, and assess whether these new techniques to determine bone quality are useful in surgery.

b) The benefits you might get from being in this study: There is no direct benefit to you by participating in this study. You may receive a certain psychological reward knowing that you are contributing to increased medical knowledgethat may help improve anti-fracture therapies in future patient populations.

8.) Other treatments you could get if you decide not to be in this study:


9.) Payments for your time spent taking part in this study or expenses:

You will receive a check in the mail for $50 following completion of your DEXA visit and a check in the mail for $50following completion of your MRI visit. This is reimbursement for your time and travel.

10.) Reasons why the study doctor may take you out of this study:

You may be taken out of this study if it is determined that you no longer meet inclusion criteria. You may also beremoved from the study if you are unable to follow study guidelines, like participating in the MRI and DEXA scanvisits. If you are taken out of this study you will be told why.

11.) What will happen if you decide to stop being in this study?


12.) Who to call for any questions or in case you are injured:

If you should have any questions about this research study or if you feel you have been hurt by being a part of thisstudy, please feel free to contact Dr. Jeff Nyman, Dr. Donald Lee, or Julie Daniels at 615-322-4506.

For additional information about giving consent or your rights as a person in this study, to discuss problems,concerns, and questions, or to offer input, please feel free to call the Vanderbilt University Institutional Review BoardOffice at (615) 322-2918 or toll free at (866) 224-8273.

13.) Clinical Trials Registry:

A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. Law. This Web sitewill not include information that can identify you. At most, the Web site will include a summary of the results. Youcan search this Web site at any time.





Information on Confidentiality, Authorization to Use/Disclose Protected Health Information,and Agreement to Participate in Study.14.) Confidentiality:

During this study every attempt will be made to keep your protected health information (PHI) private. To reduce therisk of a breach of confidentiality, most study data will be maintained in a password-protected Vanderbilt Redcapdatabase. A Vanderbilt Redcap database is a secure, web-based application for building and managing onlinedatabases. The data obtained and stored in this database will only be accessible by research personnel. All Redcapdata will be de-identified prior to statistical analysis. All OsteoProbe measurements taken will be relayed from theOsteoProbe to a laptop which his connected to the instrument during the surgical case. The imported data will bedisplayed in an excel spreadsheet. This excel spreadsheet will be saved on a password-protected computer(s) heldby research personnel. In addition, some of this data will be transferred to the Redcap study database and deletedfrom the excel file. Any physical study forms (ex. consent documents, screening forms, surveys) will be kept in alocked cabinet in the Vanderbilt Hand & Upper Extremity Center Administrative Offices for 6 years followingcompletion of the study at which time they will be disposed of in a shred-it confidentiality bin provided by VUMC.

Vanderbilt may share your information, without identifiers, to others or use it for other research projects not listed inthis form. Vanderbilt, Dr. Nyman and his staff will comply with any and all laws regarding the privacy of suchinformation. There are no plans to pay you for the use or transfer of this de-identified information.

This study may have some support from the National Institutes of Health (NIH). If so, your study information isprotected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out yourinformation even if requested using legal means. It does not protect information that we have to report by law, such as child abuse or some infectious diseases. TheCertificate does not prevent us from disclosing your information if we learn of possible harm to yourself or others, orif you need medical help. Disclosures that you consent to in this document are not protected. This includes putting research data in themedical record or sharing research data for this study or future research. Disclosures that you make yourself are alsonot protected.

15.) Authorization to Use/Disclose Protected Health Information

All efforts, within reason, will be made to keep your protected health information (PHI) private. PHI is your healthinformation that is, or has been gathered or kept by Vanderbilt as a result of your healthcare. This includes datagathered for research studies that can be traced back to you. Using or sharing ("disclosure") such data must followfederal privacy rules. By signing the consent for this study, you are agreeing ("authorization") to the uses and likelysharing of your PHI. If you decide to be in this research study, you are also agreeing to let the study team use andshare your PHI as described below.

As part of the study, Dr. Nyman and his study team may share the results of your study, as well as parts of yourmedical record, to the groups named below. These groups may include people from the: Active Life Scientific, Inc,Federal Government Office for Human Research Protections, the Vanderbilt University Institutional Review Board, andthe National Institutes of Health. Federal privacy rules may not apply to these groups; they have their own rules andcodes to assure that all efforts, within reason, will be made to keep your PHI private.

The study results will be kept in your research record for at least six years after the study is finished. At that time,the research data that has not been put in your medical record will be kept for an unknown length of time. Anyresearch data that has been put into your medical record will be kept for an unknown length of time.

Unless told otherwise, your consent to use or share your PHI does not expire. If you change your mind, we ask thatyou contact Dr. Nyman in writing and let him know that you withdraw your consent. His mailing address is 1215 21stAvenue South, Ste. 3200, Nashville, TN, 37232-8828. At that time, we will stop getting any more data about you. But, the health data we stored before you withdrew your consent may still be used for reporting and research quality. If you decide not to take part in this research study, it will not affect your treatment, payment or enrollment in anyhealth plans or affect your ability to get benefits. You will get a copy of this form after it is signed.



danielj4

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Statement by person agreeing to be in this study: I have read this consent form and the researchstudy has been explained to me verbally. All myquestions have been answered, and I freely andvoluntarily choose to take part in this study.

Patient/Volunteer Name:__________________________________(First Last)

Date:__________________________________

Consent obtained by (please enter full name andtitle): __________________________________

(Completed by study personnel at time of consent.)

Date:__________________________________





Consent Healthy Volunteer


__________________________________(First Last)


1) What is the purpose of this study?You are being asked to take part in this research study because we would like to compare the bone materialproperties in your forearm to the bone material properties of patients who have had a wrist fracture. This study islooking at new ways to predict a patient's fracture risk.

Your participation in this study will include an MRI (Magnetic Resonance Imaging) scan of one of your arms and aDEXA (Dual X-ray Absorptiometry) scan of the same arm, spine, and hips. An MRI scan uses strong magnetic fieldsand radiowaves to form images of your body. The MRI scan will be able to tell us how much bound water and porewater you have located in your arm bones for this study. A DEXA scan is used to determine bone mineral density. The DEXA scan of your arm, spine, and hips will be used in this study to determine your T-score, which is a metricused by doctors to help ascertain whether a patient has osteoporosis.

2.) What will happen and how long will you be in the study?Enrollment Visit (15-30 minutes)Your enrollment visit will take place at Vanderbilt Orthopaedic Institute or electronically via survey. You will be askedto fill out one survey about your ability to perform certain daily activities. You will also be set up to have an MRI anda DEXA scan. These scans may be on the same day.

MRI Visit (1 to 1 ½ hours)- You will undergo an MRI of one of your arms. The MRI will take place at the Vanderbilt Institute of Imaging ScienceBuilding.

DEXA Scan Visit (45 minutes to 2 hours)- You will undergo a DEXA scan of the same arm that was scanned by the MRI, your spine, and your hips. This DEXAscan will tell us your bone mineral density. The DEXA scan will take place at the Vanderbilt Clinical Research Center. If you are a female of childbearing potential, a blood sample will be collected for pregnancy testing prior to yourDEXA scan (takes up to 1 hour for test results). If you are found to be pregnant, you will not be allowed to take partin this study.

We will try to set up all of your study visits on one day, if possible.





3.) Costs to you if you take part in this study:There is no cost to you for taking part in this study.

4.) Side effects and risks that you can expect if you take part in this study:Radiation Risk from DEXA Scan (Rare)You will undergo a DEXA scan which will slightly increase your radiation exposure. This research study involvesexposure to radiation from 1 DEXA scan of your arm, spine, and hips. This radiation exposure is not necessary foryour medical care and is for research purposes only. The total amount of radiation you will receive by participating inthis study is equal to your body receiving 47 days of radiation from your natural surroundings.

Risks from MRI Scan (Rare)You will undergo an MRI scan for this study. MRIs do not use ionizing radiation so there are no harmful side-effectsassociated with temporary exposure to the strong magnetic field using by MRI scanners. The known risks of MRIsinclude:• objects brought into the room may be pulled toward the magnet (this risk will be reduced by standard operatingprocedures of MRI facilities)• a person that has an implanted metal or medical device may experience abnormal torques or fail to functionproperly (please notify the research coordinator if this applies to you)• a risk of tissue heating if there is an excessive power due to electromagnetic waves• a risk of peripheral nerve stimulation • subjects may experience a claustrophobic reaction when in the magnet (please notify the research coordinator ifthis applies to you)• there are loud banging noises with MRIs that may make you uncomfortable

Breach of Confidentiality (Rare)There is a rare chance that the confidentiality of the data we collect about you may be breached by taking part inthis study. To lower this risk, all study documents will be kept in a secure location where only research staff will haveaccess to them. All data that is recorded in an online Vanderbilt database will be password-protected, and will onlybe accessible by research personnel.

InconvenienceThe time and travel to your study visit(s) may be inconvenient for you. We will make our best effort to schedule all ofyour study visits on one day.







a) The benefits to science and humankind that might result from this study: This study is intended to determine iftwo new, non-x-ray techniques can tell the difference between bone quality in healthy volunteers, patients withhealthy bone that have had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. Thisstudy may lead to the ability to determine new techniques to predict fracture risk, determine how drug therapiesaffect bone, and determine if these new techniques to determine bone quality are useful in surgery.







Not applicable












Information on Confidentiality, Authorization to Use/Disclose Protected Health Information,and Agreement to Participate in Study.14.) Confidentiality:

During this study every attempt will be made to keep your protected health information (PHI) private. To reduce therisk of a breach of confidentiality, most study data will be maintained in a password-protected Vanderbilt Redcapdatabase. A Vanderbilt Redcap database is a secure, web-based application for building and managing onlinedatabases. The data obtained and stored in this database will only be accessible by research personnel. All Redcapdata will be de-identified prior to statistical analysis. Any physical study forms (ex. consent documents, screeningforms, surveys) will be kept in a locked cabinet in the Vanderbilt Hand & Upper Extremity Center AdministrativeOffices for 6 years following completion of the study at which time they will be disposed of in a shred-itconfidentiality bin provided by VUMC.


This study may have some support from the National Institutes of Health (NIH). If so, your study information isprotected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out yourinformation even if requested using legal means.

It does not protect information that we have to report by law, such as child abuse or some infectious diseases. TheCertificate does not prevent us from disclosing your information if we learn of possible harm to yourself or others, orif you need medical help.

Disclosures that you consent to in this document are not protected. This includes putting research data in themedical record or sharing research data for this study or future research. Disclosures that you make yourself are alsonot protected.









Unless told otherwise, your consent to use or share your PHI does not expire. If you change your mind, we ask thatyou contact Dr. Nyman in writing and let him know that you withdraw your consent. His mailing address is 1215 21stAvenue South, Ste. 3200, Nashville, TN, 37232-8828. At that time, we will stop getting any more data about you. But, the health data we stored before you withdrew your consent may still be used for reporting and research quality.

If you decide not to take part in this research study, it will not affect your treatment, payment or enrollment in anyhealth plans or affect your ability to get benefits. You will get a copy of this form after it is signed.



Date:__________________________________



Date:__________________________________





Consent Nonoperative Fx W Mri


__________________________________(First Last)


1.) What is the purpose of this study?You are being asked to take part in this research study because you have a wrist (distal radius) fracture that requiresnon-surgical intervention. This study is looking at new ways and devices that may predict a patient's fracture risk. We would like to determine the difference in bone material between healthy volunteers, patients with healthy bonethat have had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture.

Your participation in this study will include an MRI (Magnetic Resonance Imaging) scan of your non-fractured wristand a DEXA (Dual X-ray Absorptiometry) scan of your spine, hips, and non-fractured wrist. An MRI scan uses strongmagnetic fields and radiowaves to form images of your body. The MRI scan will be able to tell us how much boundwater and pore water you have located in your arm bones. A DEXA scan is used to determine bone mineral density. The DEXA scan of your arm, spine, and hips will be used in this study to determine your T-score, which is a metricused by doctors to help ascertain whether a patient has osteoporosis.

2.) What will happen and how long will you be in the study?As part of your routine care, you will have your wrist fracture placed in a cast. Your follow-up schedule is determinedby your doctor, and based on what type of treatment you receive as part of your routine clinical care.

Enrollment Visit/Before Treatment (30 minutes)• You will be asked to complete two surveys about yourself and your symptoms today• You will be scheduled for a research MRI scan and a research DEXA scan

MRI Visit (1 to 1 ½ hours)- You will undergo an MRI of your non-fractured wrist. The MRI will take place at the Vanderbilt Institute of ImagingScience Building.

DEXA Scan Visit (45 minutes to 2 hours)- You will undergo a DEXA scan of your spine, hips, and non-fractured wrist. This DEXA scan will tell us your bonemineral density. The DEXA scan will take place at the Vanderbilt Clinical Research Center. If you are a female ofchildbearing potential, a blood sample will be collected for pregnancy testing prior to your DEXA scan (takes up to 1hour for test results). If you are found to be pregnant, you will not be allowed to take part in this study.

3 Weeks After Treatment (30 minutes to 1 hour)• You will be asked to complete two surveys about yourself and your symptoms today

6 Weeks After Treatment (30 minutes to 1 hour)• You will be asked to complete two surveys about yourself and your symptoms today• Your doctor or a research coordinator will take measurements of your wrist

12 Weeks After Treatment (30 minutes to 1 hour)• You will be asked to complete two surveys about yourself and your symptoms today• Your doctor or a research coordinator will take measurements of your wrist








4.) Side effects and risks that you can expect if you take part in this study:Radiation Risk from DEXA Scan (Rare)You will undergo a DEXA scan, which will slightly increase your radiation exposure. This research study involvesexposure to radiation from 1DEXA scan of your arm, spine, and hips. This radiation exposure is not necessary foryour medical care and is for research purposes only. The total amount of radiation you will receive by participating inthis study is equal to your body receiving 47 days of radiation from your natural surroundings.

Risks from MRI Scan (Rare)You will undergo an MRI scan for this study. MRIs do not use ionizing radiation so there are no harmful side-effectsassociated with temporary exposure to the strong magnetic field using by MRI scanners. The known risks of MRIsinclude:• objects brought into the room may be pulled toward the magnet (this risk will be reduced by standard operatingprocedures of MRI facilities)• a person that has an implanted metal or medical device may experience abnormal torques or fail to functionproperly (please notify the research coordinator if this applies to you). Note that the wrist with the plating system willNOT be placed inside the magnet.• a risk of tissue heating if there is an excessive power due to electromagnetic waves• a risk of peripheral nerve stimulation • subjects may experience a claustrophobic reaction when in the magnet (please notify the research coordinator ifthis applies to you)• there are loud banging noises with MRIs that may make you uncomfortable


InconvenienceThe time and travel to your study visit(s) may be inconvenient for you. We will make our best effort to schedule theMRI and DEXA visits on one day, possibly in combination with a routine clinic visit.


























Information on Confidentiality, Authorization to Use/Disclose Protected Health Information,and Agreement to Participate in Study.





14.) Confidentiality:

During this study every attempt will be made to keep your protected health information (PHI) private. To reduce therisk of a breach of confidentiality, most study data will be maintained in a password-protected Vanderbilt Redcapdatabase. A Vanderbilt Redcap database is a secure, web-based application for building and managing onlinedatabases. The data obtained and stored in this database will only be accessible by research personnel. All Redcapdata will be de-identified prior to statistical analysis. Any physical study forms (ex. consent documents, screeningforms, surveys) will be kept in a locked cabinet in the Vanderbilt Hand & Upper Extremity Center AdministrativeOffices for 6 years following completion of the study at which time they will be disposed of in a shred-itconfidentiality bin provided by VUMC.









Unless told otherwise, your consent to use or share your PHI does not expire. If you change your mind, we ask thatyou contact Dr. Nyman in writing and let him know that you withdraw your consent. His mailing address is 1215 21stAvenue South, Ste. 3200, Nashville, TN, 37232-8828. At that time, we will stop getting any more data about you. But, the health data we stored before you withdrew your consent may still be used for reporting and research quality.

If you decide not to take part in this research study, it will not affect your treatment, payment or enrollment in anyhealth plans or affect your ability to get benefits. You will get a copy of this form after it is signed.







Date:__________________________________



Date:__________________________________





Consent Operative Fx Wo Mri


__________________________________(First Last)


1.) What is the purpose of this study?You are being asked to take part in this research study because you have a wrist (distal radius) fracture that requiressurgical intervention. This study is looking at new ways and devices that may predict a patient's fracture risk. Wewould like to determine the difference in bone material between healthy volunteers, patients with healthy bone thathave had a wrist fracture, and patients with osteoporotic bone that have had a wrist fracture. This study will involvea device called an OsteoProbe. It is a hand-held device that is applied to bone and tests bone material strength (orthe ability of bone to resist indentation).

Your participation in this study will include a DEXA (Dual X-ray Absorptiometry) scan of your spine, hips, andnon-fractured wrist. A DEXA scan is used to determine bone mineral density. The DEXA scan of your arm, spine, andhips will be used in this study to determine your T-score, which is a metric used by doctors to help ascertain whethera patient has osteoporosis.

In addition to the DEXA scan, your distal radius bone will be indented with the OsteoProbe instrument during surgeryto test your bone material strength. The OsteoProbe instrument will be applied to your bone after you have beensedated, and the incision to your arm is made. It will also occur before the surgeon repairs your distal radius fractureusing a plating system. Your surgeon will apply the instrument to your distal radius bone at up to 15 differentlocations about 2 mm apart (less than a tenth of an inch apart). Each indentation is smaller than the screws used tosecure the plating system. Once all OsteoProbe measurements have been obtained the surgeon will continue onwith routine surgery.

2.) What will happen and how long will you be in the study?As part of your routine care, you will have surgery to repair your wrist fracture. Your follow-up schedule isdetermined by your doctor, and based on what type of treatment you receive as part of your routine clinical care.

Enrollment Visit/Before Surgery (30 minutes)• You will be asked to complete two surveys about yourself and your symptoms today• You will be scheduled for a research DEXA scan

Surgery Visit (2 to 3 hours)• During your routine surgery, your surgeon will apply the OsteoProbe to your distal radius (wrist) bone at up to 15different locations about 2 mm apart. The OsteoProbe will tell us your bone material strength. DEXA Scan Visit (45 minutes to 2 hours)- You will undergo a DEXA scan of your spine, hips, and non-fractured wrist. This DEXA scan will tell us your bonemineral density. The DEXA scan will take place at the Vanderbilt Clinical Research Center. If you are a female ofchildbearing potential, a blood sample will be collected for pregnancy testing prior to your DEXA scan (takes up to 1hour for test results). If you are found to be pregnant, you will not be allowed to take part in this study.

3 Weeks After Surgery (30 minutes to 1 hour)• You will be asked to complete two surveys about yourself and your symptoms today





• You will be asked to complete two surveys about yourself and your symptoms today• Your doctor or a research coordinator will take measurements of your wrist




4.) Side effects and risks that you can expect if you take part in this study:Infection Risk (Uncommon)As with any surgical procedure there is a slight risk of infection. To minimize this risk, the OsteoProbe tip that is usedto indent your wrist bone will be sterilized prior to surgery. In addition, a sterilized sleeve will cover the otherportions of the Osteoprobe machine.

Radiation Risk from DEXA Scan (Rare)You will undergo a DEXA scan, which will slightly increase your radiation exposure. This research study involvesexposure to radiation from 1DEXA scan of your arm, spine, and hips. This radiation exposure is not necessary foryour medical care and is for research purposes only. The total amount of radiation you will receive by participating inthis study is equal to your body receiving 47 days of radiation from your natural surroundings.


InconvenienceThe time and travel to your study visit(s) may be inconvenient for you. We will make our best effort to schedule theDEXA visit in combination with a routine clinic visit.















You will receive a check for $50 following completion of your DEXA visit. This is reimbursement for your time andtravel.


You may be taken out of this study if it is determined that you no longer meet inclusion criteria. You may also beremoved from the study if you are unable to follow study guidelines, like participating in the DEXA scan visit. If youare taken out of this study you will be told why.








Information on Confidentiality, Authorization to Use/Disclose Protected Health Information,and Agreement to Participate in Study.





14.) Confidentiality:

During this study every attempt will be made to keep your protected health information (PHI) private. To reduce therisk of a breach of confidentiality, most study data will be maintained in a password-protected Vanderbilt Redcapdatabase. A Vanderbilt Redcap database is a secure, web-based application for building and managing onlinedatabases. The data obtained and stored in this database will only be accessible by research personnel. All Redcapdata will be de-identified prior to statistical analysis. All OsteoProbe measurements taken will be relayed from theOsteoProbe to a laptop which his connected to the instrument during the surgical case. The imported data will bedisplayed in an excel spreadsheet. This excel spreadsheet will be saved on a password-protected computer(s) heldby research personnel. In addition, some of this data will be transferred to the Redcap study database and deletedfrom the excel file. Any physical study forms (ex. consent documents, screening forms, surveys) will be kept in alocked cabinet in the Vanderbilt Hand & Upper Extremity Center Administrative Offices for 6 years followingcompletion of the study at which time they will be disposed of in a shred-it confidentiality bin provided by VUMC.









Unless told otherwise, your consent to use or share your PHI does not expire. If you change your mind, we ask thatyou contact Dr. Nyman in writing and let him know that you withdraw your consent. His mailing address is 1215 21stAvenue South, Ste. 3200, Nashville, TN, 37232-8828. At that time, we will stop getting any more data about you. But, the health data we stored before you withdrew your consent may still be used for reporting and research quality.If you decide not to take part in this research study, it will not affect your treatment, payment or enrollment in anyhealth plans or affect your ability to get benefits. You will get a copy of this form after it is signed.







Date:__________________________________



Date:__________________________________



Documents

Vanderbilt University Institutional Review Board Informed ...The MRI will take place at the Vanderbilt Institute of Imaging Science Building. DEXA Scan Visit (45 minutes to 2 hours)-