chronOS Vivify. The new perfusion - Limelight Networkssynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · chronic osteomyelitis) and soft-tissue infections –

The answer tobone voids

chronOS Vivify. The new perfusionconcept enhancing chronOS withbiological factors.

Technique Guide

0X6.001.338_AA 16.01.12 08:06 Seite Cvr1

0X6.001.338_AA 16.01.12 08:06 Seite Cvr2

chronOS Vivify Technique Guide Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

Bibliography

Overview 2Description 2chronOS Perfusion Concept 3Features and Benefits 4Design 5

Indications and Contraindications 6

Animal Study 7

Preparation 8

Perfusion of chronOS Vivify Implant 9

Removal of chronOS Vivify Implant from Pouch 12

Implantation of chronOS Vivify 13

Implants and Instruments 14

Bibliography 16

Image intensifier control

WarningThis description alone does not provide sufficient background for direct use ofthe product. Instruction by a surgeon experienced in handling this product ishighly recommended.

Reprocessing, Care and Maintenance of Synthes InstrumentsFor general guidelines, function control and dismantling of multi-part instruments,please contact your local sales representative or refer to:www.synthes.com/reprocessing

0X6.001.338_AA 16.01.12 08:06 Seite 1

2 Synthes chronOS Vivify Technique Guide

OverviewDescription

chronOS products are widely used as synthetic, osteoconductive bone graft substitutes for indications in trauma,spine and cranio-maxillofacial surgery. chronOS is a highlyporous matrix made of pure �-tricalcium phosphate. Due toits interconnected pores, the material serves as an ideal, osteoconductive matrix for the formation of new bone. It isremodeled into host bone within 6 to 18 months; dependingon patient conditions.

chronOS ceramic contains a significant amount of air in itspores. Impregnation of the porous material with bone marrow or blood not only removes the air but introducesblood cells, growth factors and, in the case of bone marrow,osteoprogenitor cells into the bone graft substitute. Thecombination of chronOS with bone marrow accelerates andenhances osteointegration and is a valuable alternative toautologous or allogenic bone graft material (Stoll et al, 2004and Becker et al, 2006).

In order to make the osteoinductive and osteogenic poten-tial of autologous bone marrow available, Synthes has devel-oped the chronOS Perfusion Concept allowing the efficient,intra-operative impregnation of chronOS products with thepatient’s own bone marrow.

chronOS Vivify is the new and improved version of thechronOS Perfusion System. With chronOS Vivify, the implantscome in special perfusion pouches that allow for simple perfusion with bone marrow aspirate or blood. Togetherwith the Bone Marrow Aspiration System (BMAS) and theidea of perfusion, the chronOS Vivify implants form thenew Perfusion Concept.

0X6.001.338_AA 16.01.12 08:06 Seite 2

+ + +

–

–

+ + +

+

+

+ + +

+ + +

–

+ + +

+ + +

+ + +


Step 1Aspiration of bone marrow

Step 2Perfusion under vacuum

Step 3Implantation of chronOS Vivify

chronOS chronOS Vivifyperfused with bonemarrow

DBX Autograft

OsteoconductiveBiological property:

Matrix

Growth factors

Osteoprogenitor

Osteopromotive Osteoinductive Osteogenic

Overview

chronOS Perfusion Concept

0X6.001.338_AA 16.01.12 08:06 Seite 3

4.1%

42.8%

53.1%

16.5%

40.4%

43.1%

Enhanced osteointegrationThe diagrams show the amount of chronOS that was resorbed and remodeled into new host bone 6 weeks after implantation in a sheep animal model. The fractions of non-resorbed chronOS and the remaining non-mineralizedtissue (connective tissue, fat tissue, fibroblasts, air, prepara-tion artifacts) are indicated. More than four times morenew bone was formed when bone marrow (upper diagram)was used to perfuse the chronOS Vivify implant compared to perfusion with blood (lower diagram). (Becker et al., 2006)

Overview

Features and Benefits


Due to the highly porous nature of chronOS Vivify, simpledipping of the ceramic material in bone marrow or bloodonly leads to a partial impregnation at the borders. Perfusionunder vacuum is required to force the air out of the pores

and bring the viscous fluid into the center of chronOS Vivifyimplants. For easy handling, chronOS Vivify productsare available pre-packaged in a special perfusion pouch that allows thorough perfusion.

Feature Benefit

Autologous bone marrow Osteopromotion: accelerated and enhanced osteointegration

Vacuum perfusion system Efficient impregnation of chronOS with bone marrow

Intra-operative aspiration technique Time and cost saving procedure(up to 5 times faster than bone grafting1)

Minimally invasive procedure Reduced morbidity

Synthetic origin of chronOS Avoids potential problems common for grafting methods

Optimized porosity of chronOS Enhanced bone ingrowth and vascularization

1 Bone marrow can be harvested in 2–3 minutes whereas grafting of autologous bone takes up to 10–15 minutes.

Blood

Bone marrow

new bone

non-mineralized tissue

non-resorbed chronOS

0X6.001.338_AA 16.01.12 08:06 Seite 4

Overview

Design


chronOS Vivify implants are made of pure �-tricalcium phos-phate. The elaborate porous structure of the ceramic material ensures that it acts as an osteoconductive matrix forthe ingrowth of bone cells and blood vessels. As a rule,chronOS Vivify implants are resorbed within 6 to 18 months(depending on the patient’s conditions) and are convertedinto autogenous bone. Due to their composition, chronOSVivify implants are initially radio-opaque.

The Bone Marrow Aspiration System (BMAS) is a compact,self-contained kit including a 20 ml syringe with a Luer lockfitting and an 11 gauge Jamshidi style bone marrow aspira-tion needle, available in 11 and 15 cm lengths. For bothlengths the biopsy needles feature additional side holes to increase bone marrow yield. All components are sterile pack-aged in a disposable kit for single-procedure use. The BMASis compatible with the other components of the chronOSPerfusion Concept allowing a direct transfer of the bonemarrow into the perfusion pouch containing the chronOSVivify implants.

The specially developed perfusion pouch allows simple, effective intra-operative vacuum impregnation of all chronOSVivify preforms. According to their size, chronOS Vivify cylinders, blocks and wedges are pre-packaged in either asmall or large perfusion pouch.

Small pouch

Large pouch

chronOS Vivify pouches

Bone Marrow Aspiration System

Stylet Syringe 20 ml (green) Biopsy needle

0X6.001.338_AA 16.01.12 08:06 Seite 5


Indications and Contraindications

Indications*The Bone Marrow Aspiration System (BMAS) is indicated for aspirating bone marrow.

chronOS Vivify implants should be used as bone void fillersor augmentation material in zones requiring cancellousrather than cortical bone. This includes the filling of bone de-fects after trauma, reconstruction or correction in non-loadbearing indications only. Depending on the size, voids of undefined geometric shape can be filled with granules orcombinations of granules and blocks. Voids with definedgeometric shape can be filled with blocks, wedges or cylin-ders.

Trauma and orthopedicsFor example filling of voids caused by cysts or osteotomies,filling of defects arising from impacted fractures, refilling ofcancellous bone harvesting sites, arthrodesis, non-unions andpseudarthrosis.

Spine surgeryFor example postero-lateral fusion, vertebrectomies (as fillingmaterial of the vertebral implants), refilling of bone graft har-vesting sites.

Cranio-maxillofacial surgeryFor example reconstruction of mandibular cyst defects andvoids after tooth socket extractions and the maxillary sinus.

Contraindications* chronOS Vivify implants should not be used in the following circumstances:– Acute and chronic infections in the operation area, e.g.

inflammation, bacterial bone diseases (posttraumatic orchronic osteomyelitis) and soft-tissue infections

– Malignant myeloma, Burkitt’s lymphoma, and other lymphomas

– Defects and fractures in the region of an open epiphysis – Osteoporosis – Severe instability or deformation at the extraction point

(harvesting site)

chronOS Vivify implants are not indicated for use in loadbearing and unstable indications unless used in conjunctionwith appropriate osteosynthesis fixation systems or except ifthe cortical bone can bear the full load.

*For complete indications, contraindications, precautions and warning notices,please refer to the instructions for use.

0X6.001.338_AA 16.01.12 08:06 Seite 6


Animal Study

Blood Bone marrow

6 weeks post-op 6 weeks post-op

12 weeks post-op 12 weeks post-op

An animal study was performed to evaluate the osteogenicpotential of autologous substances like bone marrowand blood processed intraoperatively and combined with a synthetic ceramic bone substitute.

Critical size defects (8.5 mm cylindrical, 20 mm length) weresurgically created on the left and the right tibia metaphysisof adult sheep. The artificial defects were filled with chronOSVivify cylinders that were perfused with either blood (left) orbone marrow (right). Resorption of chronOS Vivify and re-generation of host bone was analyzed histologically at 6 (toplane) and 12 (bottom lane) weeks postoperative.

Osteointegration was significantly more pronounced forchronOS Vivify implants impregnated with bone marrowrather than with blood. After 12 weeks, most of thechronOS Vivify implant was remodeled into host bone whenbone marrow was used, whereas the bone substitute mate-rial was still clearly visible when impregnated with blood.

For details see: Stoll et al., 2004 and Becker et al., 2006.

0X6.001.338_AA 16.01.12 08:06 Seite 7


Surgical considerationschronOS Vivify implants must always be applied by enossealor subperiosteal implantation, i.e. by direct contact with the vital bone.

It is recommended to aspirate bone marrow and to preparethe chronOS Vivify/bone marrow combination directly beforeimplantation. However, if required, bone marrow (BM) canbe harvested prior to using the chronOS Vivify/BM hybrid implant. In this case it is recommended to combine the aspi-rated bone marrow immediately with the chronOS Vivifyproduct before clotting occurs. Store the chronOS Vivify/BMcombination implant wrapped in a humid cloth for up to amaximum of 30 minutes (storage in the refrigerator is not required).

Note: For more information on the surgical technique for aspirating bone marrow refer to the technique guideBone Marrow Aspiration System (BMAS), 036.001.020.

Preparation

0X6.001.338_AA 16.01.12 08:06 Seite 8

1

2


Perfusion of chronOS Vivify Implant

1Perfuse chronOS Vivify implant

Optional systems

710.111S Bone Marrow Aspiration System (Biopsy Needle: 11 ga�11.0 cm, with Side Holes), sterile

710.151S Bone Marrow Aspiration System (Biopsy Needle: 11 ga�15.0 cm, with Side Holes), sterile

Aspirate bone marrow using the bone marrow aspiration system or fill a syringe with the patient’s blood.

Note: For more information on the surgical technique for aspirating bone marrow refer to the technique guide“Bone Marrow Aspiration System (BMAS)”, 036.001.020.

Unscrew the protective cap on the perfusion pack port. (1)

Attach the syringe containing fluid to the Luer fitting on theperfusion pouch. (2)

0X6.001.338_AA 16.01.12 08:06 Seite 9

3


Fill the perfusion pouch with fluid following the recommended volume ranges such that the chronOS Vivifyimplant appears thoroughly wetted. (3)

Recommended volumes for perfusion of chronOS Vivify implants

chronOS Vivify Cylinders

� (mm) Perfusion pouch Perfusion volume range (ml)

8.5 Small 5– 8

9.5 Small 5– 8

10.5 Small 5– 8

12.5 Large 8–10

14.0 Large 8–10

chronOS Vivify Blocks

Size (mm) Perfusion pouch Perfusion volume range (ml)

5�5�10 Small 2– 5

12.5�12.5�10 Small 5– 8

20�20�10 Small 8–10

chronOS Vivify Wedge

Angle Perfusion pouch Perfusion volume range (ml)

10° Small 5– 8

14° Small 8–10

18° Small 8–10

22° Large 8–10

26° Large 8–10

chronOS Vivify Wedge, semi-circular

Angle Perfusion pouch Perfusion volume range (ml)

7° Large 8–10

10° Large 8–10

13° Large 10–12

Perfusion of chronOS Vivify Implant

0X6.001.338_AA 16.01.12 08:06 Seite 10

4


Perfuse the chronOS Vivify implant by gently pumping thesyringe plunger 10 to 15 times.

Allow a back flow of fluid into the syringe before pumping itagain into the pouch. (4)

Caution: Do not exceed the recommended upper volumelimit as this may over-pressurize the perfusion pouch.

Note: Do not pull the syringe plunger back to its maximumstroke as this may cause the plunger to disengage from thesyringe barrel, resulting in the loss of the syringe contents.

0X6.001.338_AA 16.01.12 08:06 Seite 11

1


Removal of chronOS Vivify Implantfrom Pouch

Remove the syringe to relieve any pressure from the perfusion pouch.

Remove the implant by grasping it through the perfusionpouch to secure it, while tearing at the designated notch atthe top of the pouch (1).

0X6.001.338_AA 16.01.12 08:06 Seite 12


Implantation of chronOS Vivify

Please refer to the chronOS product documentation for detailed instructions on how to use chronOS.

HandlingchronOS Vivify implants must always be applied by enossealor subperiosteal implantation, i.e. by direct contact withthe vital bone. The surgical procedure depends on the local-ization, nature and extent of the bone defect. To preparethe implant site, remove all inflammatory necrotic tissue andbone particles.

The appropriate implant size is determined by the size of thebone defect, the vascularity and the size of the cancellousbone chips, if used. Keep the regions of enosseal vessel andnerve cords clear to avoid pressure sores.

The use of the Perfusion Concept facilitates the enrichmentof chronOS Vivify implants with the patient's own bone mar-row or blood. The chronOS Vivify preforms are available pre-packaged in a perfusion system. The implant must com-pletely fill the bone defect (press-fit). However, it is essentialto avoid over-filling to ensure tension-free wound closure.

Note: Handle perfused chronOS Vivify implants with care toavoid damage.

0X6.001.338_AA 16.01.12 08:06 Seite 13

Implants and Instruments

chronOS Vivify Cylinders

Art. No. � mm Length mm Perfusion pouch

07.720.030S 8.5 25 Small

07.720.031S 9.5 25 Small

07.720.032S 10.5 25 Small

07.720.033S 12.5 25 Large

07.720.035S 14.0 25 Large

chronOS Vivify Wedges

Art. No. Angle Size (mm) Perfusion pouch

07.720.050S 10° 25�20�6 Small

07.720.051S 14° 25�20�8 Small

07.720.052S 18° 25�20�10 Small

07.720.053S 22° 25�20�12 Large

07.720.054S 26° 25�20�14 Large

chronOS Vivify Blocks

Art. No. Size (mm) Perfusion pouch

07.720.042S 5�5�10 Small

07.720.045S 12.5�12.5�10 Small

07.720.047S 20�20�10 Small

chronOS Vivify Wedges, semi-circular

Art. No. Angle Size (mm) Perfusion pouch

07.720.057S 7° 25�35�7 Large

07.720.060S 10° 25�35�10 Large

07.720.063S 13° 25�35�13 Large


0X6.001.338_AA 16.01.12 08:06 Seite 14


chronOS Granules*

Art. No. � (mm) Content (ml)

710.000S 0.5– 0.7 0.5

710.001S 0.7– 1.4 0.5

710.002S 0.7– 1.4 1.0

710.003S 0.7– 1.4 2.5

710.011S 1.4– 2.8 2.5

710.014S 1.4– 2.8 5.0

710.019S 1.4– 2.8 10.0

710.021S 1.4– 2.8 20.0

710.024S 2.8– 5.6 2.5

710.025S 2.8– 5.6 5.0

710.026S 2.8– 5.6 10.0

710.027S 2.8– 5.6 20.0

Bone Marrow Aspiration System (BMAS)

Art. No. � (ga) Length (mm) Side holes Syringe (ml)

710.111S 11 11 yes 20

710.151S 11 15 yes 20

chronOS granules are not offered in a perfusion device. Theycan easily be combined with autologous bone marrow orblood in a sterile bowl.

*Not available in pouch

0X6.001.338_AA 16.01.12 08:06 Seite 15


Bibliography

chronOS Vivify: optimized scaffold induces remodeling processWheeler D. (2005) Grafting of Massive Tibial SubchondralBone Defects in a Caprine Model Using �-Tricalcium Phos-phate Versus Autograft. J Orthop Trauma, Volume 19 (2),85–91

Lu JX, Flautre B et al. (1999) Role of interconnections inporous bioceramics on bone recolonization in vitro and vivo.J Mater Sci Mater Med, 10, 111–120

Bone marrow harvesting technique: reduced morbidityBertram H, Mayer H, Schliephake H. (2005) Effect of donorcharacteristics, technique of harvesting and in vitro process-ing on culturing of human marrow stroma cells for tissue engineered growth of bone. Clin Oral Implants Res, 16(5), 524–31

Kitchel SH, Wang MY, Lauryssen CL. (2005) Techniques forAspirating Bone Marrow for Use in Spinal Surgery. Neuro-surgery, 57(4), 286–289

Bone marrow: osteogenic potentialConnolly J. (1995) Injectable bone marrow preparations tostimulate osteogenic repair. Clin Orth Rel Res, 313, 8–18

Tiedeman et al. (1991) Healing of a large nonossifying fibroma after grafting with bone matrix and marrow, Clin.Orth. Rel. Res., 265, 302–305

Connolly J. et al. (1989) Autologous marrow injection for delayed unions of the tibia: a preliminary report. J OrthopTrauma, 3 (4), 276–282

Vacuum perfusion: efficient impregnation of chronOS Vivify withbone marrowBecker et al. (2006) Osteopromotion by a �-TCP/Bone Marrow Hybrid Implant for Use in Spine Surgery. Spine, Volume 31(1), 11–17

Stoll et al. (2004) New Aspects in Osteoinduction. Mat.-wiss.u. Werkstofftech, 35 (4), 198–202

0X6.001.338_AA 16.01.12 08:06 Seite 16

0X6.001.338_AA 16.01.12 08:06 Seite Cvr3

0123All technique guides are available as PDF files at www.synthes.com/lit

Ö036.001.338öAAHä

036.

001.

338

vers

ion

AA

01

/201

270

1000

99

© S

ynth

es, I

nc. o

r its

aff

iliat

es

Subj

ect

to m

odifi

catio

ns

Synt

hes

is a

tra

dem

ark

of S

ynth

es, I

nc. o

r its

aff

iliat

es

0X6.001.338_AA 16.01.12 08:06 Seite Cvr4

Documents

chronOS Vivify. The new perfusion - Limelight Networkssynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · chronic osteomyelitis) and soft-tissue infections –