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Latest Advancements In Coblation Technology for Treatment of Knee

Pathology

RALPH A. GAMBARDELLA, M.D.

KERLAN-JOBE ORTHOPAEDIC CLINIC

LOS ANGELES, CA

Disclaimer

The information presented is solely for training purposes. It is not intended for distribution to customers, surgeons, or user facilities. Promotion of ArthroCare products is to be on-label and consistent with approved indications and intended uses.

The information in this presentation is considered proprietary and is not to be copied or distributed.

DISCLOSURE

Consultant:

ArthroCare

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®

• Broad range of experience

• Technology used by most in some way

• Negative press over 12 years ago

• An opportunity to revisit:

• Proper use of the technology

• Old and recent scientific studies • Share our clinical experience of 15yrs

• Coblation technology has been used clinically in over 6 million procedures

• Over 16 years of clinical use

• Over 1 million knee procedures

• Technology Overview – Plasma Formation

–Power Curve & Setting

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Plasma Formation (Chemical Process)

1. Current Flows to the Distal Electrode 3. Micro Bubbles Expand into a Vapor Layer

4. Energized Radicals Fire across Vapor Layer to create a contained Plasma field 2. Micro bubbles form

Tissue Effect at Ablative Set Points

Set Point 1 Set Point 4 Set Point 7 Set Point 9

• Coblation operates at lower temperatures than other RF Technologies

• 100µ - 200µ plasma field allows for precise removal of soft tissue with minimal thermal damage to untargeted tissue

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Note: Results from preclinical studies have not been shown to correlate with clinical outcomes. These data are presented to provide perspective on basic science being performed relative to Coblation.

Note: Results from preclinical studies have not been shown to correlate with clinical outcomes. These data are presented to provide perspective on basic science being performed relative to Coblation.

Literature References 1. Lu Y, Markel MD, et al. Thermal Chondroplasty with Radiofrequency. An in Vitro Comparison of Bipolar and Monopolar Radiofrequency

Devices Am J Sports Med. 2001 Jan-Feb;29(1):42-9

2. Lu Y, Markel MD, et al. Effect of bipolar radiofrequency energy on human articular cartilage. Comparison of confocal laser microscopy and light microscopy Arthroscopy. 2001 Feb;17(2):117-23

3. Lu Y, Markel MD, et al. The effect of monopolar radiofrequency energy on partial-thickness defects on articular cartilage Arthroscopy. 2000 Jul

4. Lu Y, Markel MD, et al. Thermal chondroplasty with bipolar and monopolar radiofrequency energy: Effect of treatment time on chondrocyte death and surface contouring Arthroscopy. 2002 Sep;18(7):779-88 -Aug;16(5):527-36

5. Kaplan LD, et al. The Thermal Field of RF Probes at Chondroplasty Settings Arthroscopy. 2003 Jul-Aug;19(6):632-40

6. Turner AS, et al. Radiofrequency (Electrosurgical) Ablation of Articular Cartilage: A Study in Sheep Arthroscopy. 1998 Sep;14(6):585-91

7. Lotto ML, et al. Ex vivo Comparison of Mechanical Versus Thermal Chondroplasty: Assessment of Tissue Effect at the Surgical Endpoint Arthroscopy. 2008 Apr;24(4):410-5

8. Lotto ML, et al. An Ex Vivo Thermal Chondroplasty Model: The Association of a Char-Like Layer and Underlying Cell Death Arthroscopy. 2006 Nov;22(11):1159-62

9. Owens BD, et al. Prospective Analysis of RF Versus Mechanical Debridement of Isolated Patellar Chondral Lesions Arthroscopy. 2002 Feb18(2):151-5

10. Cetik O, et al. Risk of Osteonecrosis of the Femoral Condyle after Arthroscopic Chondroplasty using Radiofrequency: A Prospective Clinical Series Knee Surg Sports Traumatol Arthrosc. 2009 Jan; 17(1):24-9

11. Allen TR et al. Meniscal Debridement with an Arthroscopic Radiofrequency Wand Versus an Arthroscopic Shaver: Comparative Effects on Menisci and Underlying Articular Cartilage J Arthroscopic & Related Surgery. 2006; 22(4):385–393

12. Amiel D, Ball ST, Tasto JP. Chondrocyte Viability and Metabolic Activity after Treatment of Bovine Articular Cartilage with Bipolar RF Arthroscopy. 2004 May; 20(5):503-10

13. Zoric BB, et al. Factors Influencing Intra-Articular Fluid Temperature Profiles with RF Ablation JBone Joint Surg. 2009; 91(10):2448-2454

14. Kaplan L, Uribe JW. The Acute Effects of Radiofrequency Energy in Articular Cartilage: An in Vitro Study Arthroscopy 2000 Jan-Feb;16(1):2-5

15. Voloshin I, et al. Arthroscopic Evaluation of Radiofrequency Chondroplasty of the Knee Am J Sports Med. 2007 Oct; 35(10):1702-7

16. Spahn G et al. Arthroscopic Knee Chondroplasty Using a Bipolar RF Based Device Compared to Mechanical Shaver: Results of a Prospective, Randomized Controlled Study Knee Surg Sports Traumatol Arthroscopy. 2008 Jun; 16(6):565-73

17. Spahn G et al. Four-Year Results From a Randomized Controlled Study of Knee Chondroplasty With Concomitant Medial Meniscectomy: Mechanical Debridement Versus RF Chondroplasty Arthroscopy 2010 Sept; 26(9):S73-S80

Literature References*

1. Lu Y, Markel MD, et al. Thermal Chondroplasty with Radiofrequency. An in Vitro Comparison of Bipolar and Monopolar Radiofrequency Devices Am J Sports Med. 2001 Jan-Feb;29(1):42-9

2. Amiel D, Ball ST, Tasto JP. Chondrocyte Viability and Metabolic Activity after Treatment of Bovine Articular Cartilage with Bipolar RF Arthroscopy. 2004 May; 20(5):503-10

P/N 44333_A

* These articles have been selected from the full literature analysis due to their specific relevance to the discussed topics here

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Thermal chondroplasty with radiofrequency An in vitro comparison of bipolar and monopolar radiofrequency devices

Lu Y, Markel MD, et al. Am J Sports Med. 2001 Jan-Feb;29(1):42-9.

Purpose: The purpose of this study was to examine the in vitro

effects of three radiofrequency energy devices (two bipolar devices and one monopolar device) for the performance of thermal chondroplasty.

Methods: Thirty-two fresh bovine femoral osteochondral sections (approximately 3 x 4 x 5 cm) from eight cows were divided into four groups

(three treatment patterns and one sham-operated group with eight specimens per group). The three treatment patterns consisted of 1) radiofrequency energy delivered by a mechanical jig at 1 mm/sec in a contact mode (50 g of pressure),

2) radiofrequency energy delivered by a mechanical jig at 1 mm/sec in a noncontact mode (1 mm between probe tip and articular cartilage surface), and 3) radiofrequency energy smoothing of abraded cartilage during arthroscopic

visualization. Thermal smoothing of the abraded cartilage surface was accomplished with all three devices.

Results: Significant chondrocyte death, as determined by confocal laser microscopy and cell viability staining, was observed with each device. The bipolar radiofrequency systems penetrated 78% to 92% deeper than the monopolar

system. The bipolar systems penetrated to the level of the subchondral bone in all osteochondral sections during arthroscopically guided paintbrush pattern treatment.

Conclusion: Radiofrequency energy should not be used for thermal chondroplasty until further work can establish consistent methods for limiting

the depth of chondrocyte death while still achieving a smooth articular surface. Study Limitations:

• Study utilized technique of light contact with tissue surface (50 g contact pressure) which is not indicated by manufacturer • Needed pressure was deemed consistent between monopolar and bipolar

• Device used at setting 2, outside of manufacturer’s recommendation • Immediate post-treatment staining under confocal laser microscopy could lead to false-positive outcomes because there was no short-term recovery period

Animal In-Vitro Prospective, Randomized Non- ArthroCare Device

P/N 43140

Confocal microscopic image demonstrating radiofrequency energy-treated cartilage surface (top of each image) and subchondral bone (bottom of each image) using the

mechanical jig in contact mode (original magnification, 32). The green dots indicate viable chondrocytes and the red dots indicate dead chondrocytes. A, control. B, Oratec monopolar radiofrequency energy treatment caused immediate

chondrocyte death and a clear “dead zone” appeared. C, Mitek bipolar radiofrequency energy treatment caused immediate chondrocyte death and a clear dead zone appeared wider and extended to subchondral bone in three of eight

specimens. D, ArthroCare bipolar radiofrequency energy treatment caused immediate chondrocyte death and a clear dead zone appeared wider and also

extended to subchondral bone in three of eight specimens. The white bar

demonstrates the boundary between the cartilage and subchondral bone.

Chondrocyte Viability and Metabolic Activity after Treatment of Bovine Articular Cartilage with Bipolar RF

Purpose: Examine the chondrocyte viability and metabolic activity after treatment of fresh bovine articular cartilage

with RF probes. Methods: Three fresh bovine knees served as a baseline control for chondrocyte viability, yielding 6 samples (1 from each medial femoral condyle and 1 from each lateral femoral condyle). After the baseline expected

chondrocyte viability was determined, 3 additional bovine knees served as the experimental specimens for the study. Under sterile conditions, 2 different bipolar RF probes were used to treat the articular surface in a light contact mode, moving at a linear rate of 3 to 4 mm/s to provide tissue debridement. Full -thickness articular cartilage was then harvested from each of the treatment areas. Six samples per probe were then assessed for chondrocyte viability using fluorescent double staining followed by confocal

microscopy; 6 samples per probe were assessed for metabolic activity using an 35SO4 incorporation assay; and 12 additional untreated samples were obtained to serve as controls for viability (n=6) and metabolic activity (n=6). Results:

The depth of chondrocyte death (mean ± standard deviation) was 109.4 ± 22.1 microns after treatment with the ACD-50 probe, and was 172.3 ± 34.3 microns after treatment with the 2.5mm/90 degree probe. The 35SO4 uptake (mean ± standard deviation) was 2584 ± 1388 cpm/mg dry cartilage for the ACD-50 probe and 1995 ± 852 cpm/mg of dry cartilage for the 2.5mm/90 degree probe. The 35SO4 uptake for the control was 2647 ± 1380 cpm/mg dry cartilage.

Conclusions: The 2 probes tested created a well controlled debridement with smooth edges and a defined margin of chondrocyte death that extended approximately 100 to 200 microns deep to the treatment area. There does not appear to be a significant effect on the metabolic activity of the chondrocytes adjacent to the

treatment zone, but with the small sample size we lacked sufficient statistical power to definitively determine these effects. Study Limitations: • A wide variety of RF probes exist, and individual probes clearly have different characteristics.

• A number of methods of application can be used (contact v noncontact, linear sweep v paintbrush, surface annealing v debridement). These conclusions should only be applied to the probes tested and the conditions under which they were tested.

• Further laboratory study is clearly warranted to further define the role of RF probes in arthroscopy and the methods with which they should be used.

• Long-term prospective studies should be undertaken with magnetic resonance imaging or second look arthroscopic evaluation to appropriately assess the effects on articular cartilage.

Articular cartilage specimens treated with ACD-50 on the medial condyle

Amiel D, Ball ST, Tasto JP. Arthroscopy. 2004 May; 20(5):503-10. Animal In-Vitro ArthroCare Device

P/N 43140

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Surgical Objective

Minimize • Removal of healthy

AC

• Collateral damage

Leave • Smooth surface

• Stable rim

Desired Technique

• Use recommended controller setting per device instructions

• Activate device off tissue

• Move tip over tissue in paintbrush fashion; 1-2 mm / sec

• Work just off or barely contacting surface

Chondroplasty

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Chondroplasty

Chondroplasty Trochlea

Meniscectomy

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Conclusions

Remember

It may not be what is at this end ...

... but at this end,

that makes the difference!

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Thank You!

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Knee Arthroscopy : Optimizing Care with Coblation

Technology

Aakash A. Shah, M.D.

VuMedi Webinar

March 5, 2014

Disclosure

• Physician Consultant

– Arthrocare

Epidemiology

• 984,607 outpatient knee arthroscopies performed in 2006

• Most common orthopaedic surgery performed

• Most common concomitant finding is articular chondral wear

• Is the pathology so common, we have started to dismiss its significance?

Increase in outpatient knee arthroscopy in the United States: a comparison of National Surveys of Ambulatory Surgery, 1996 and 2006; JBJS 2011.

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Surgeon Goals

• Reassess our abilities at surgery

• Provide options at surgery

• No recommendations to change surgeon’s intent or procedure

Working towards improving the current

standard of care

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Note: Results from preclinical studies have not been shown to correlate with clinical outcomes. These data are presented to provide perspective on basic science being performed relative to Coblation.

• Human In-Vivo Studies

Literature References 1. Lu Y, Markel MD, et al. Thermal Chondroplasty with Radiofrequency. An in Vitro Comparison of Bipolar and Monopolar

Radiofrequency Devices Am J Sports Med. 2001 Jan-Feb;29(1):42-9

2. Lu Y, Markel MD, et al. Effect of bipolar radiofrequency energy on human articular cartilage. Comparison of confocal laser microscopy and light microscopy Arthroscopy. 2001 Feb;17(2):117-23

3. Lu Y, Markel MD, et al. The effect of monopolar radiofrequency energy on partial-thickness defects on articular cartilage Arthroscopy. 2000 Jul

4. Lu Y, Markel MD, et al. Thermal chondroplasty with bipolar and monopolar radiofrequency energy: Effect of treatment time on chondrocyte death and surface contouring Arthroscopy. 2002 Sep;18(7):779-88 -Aug;16(5):527-36

5. Kaplan LD, et al. The Thermal Field of RF Probes at Chondroplasty Settings Arthroscopy. 2003 Jul-Aug;19(6):632-40

6. Turner AS, et al. Radiofrequency (Electrosurgical) Ablation of Articular Cartilage: A Study in Sheep Arthroscopy. 1998 Sep;14(6):585-91

7. Lotto ML, et al. Ex vivo Comparison of Mechanical Versus Thermal Chondroplasty: Assessment of Tissue Effect at the Surgical Endpoint Arthroscopy. 2008 Apr;24(4):410-5

8. Lotto ML, et al. An Ex Vivo Thermal Chondroplasty Model: The Association of a Char-Like Layer and Underlying Cell Death Arthroscopy. 2006 Nov;22(11):1159-62

9. Owens BD, et al. Prospective Analysis of RF Versus Mechanical Debridement of Isolated Patellar Chondral Lesions Arthroscopy. 2002 Feb18(2):151-5

10. Cetik O, et al. Risk of Osteonecrosis of the Femoral Condyle after Arthroscopic Chondroplasty using Radiofrequency: A Prospective Clinical Series Knee Surg Sports Traumatol Arthrosc. 2009 Jan; 17(1):24-9

11. Allen TR et al. Meniscal Debridement with an Arthroscopic Radiofrequency Wand Versus an Arthroscopic Shaver: Comparative Effects on Menisci and Underlying Articular Cartilage J Arthroscopic & Related Surgery. 2006; 22(4):385–393

12. Amiel D, Ball ST, Tasto JP. Chondrocyte Viability and Metabolic Activity after Treatment of Bovine Articular Cartilage with Bipolar RF Arthroscopy. 2004 May; 20(5):503-10

13. Zoric BB, et al. Factors Influencing Intra-Articular Fluid Temperature Profiles with RF Ablation JBone Joint Surg. 2009; 91(10):2448-2454

14. Kaplan L, Uribe JW. The Acute Effects of Radiofrequency Energy in Articular Cartilage: An in Vitro Study Arthroscopy 2000 Jan-Feb;16(1):2-5

15. Voloshin I, et al. Arthroscopic Evaluation of Radiofrequency Chondroplasty of the Knee Am J Sports Med. 2007 Oct; 35(10):1702-7

16. Spahn G et al. Arthroscopic Knee Chondroplasty Using a Bipolar RF Based Device Compared to Mechanical Shaver: Results of a Prospective, Randomized Controlled Study Knee Surg Sports Traumatol Arthroscopy. 2008 Jun; 16(6):565-73

17. Spahn G et al. Four-Year Results From a Randomized Controlled Study of Knee Chondroplasty With Concomitant Medial Meniscectomy: Mechanical Debridement Versus RF Chondroplasty Arthroscopy 2010 Sept; 26(9):S73-S80

Literature References* 1. Voloshin I, et al. Arthroscopic Evaluation of Radiofrequency Chondroplasty of the Knee Am J Sports

Med. 2007 Oct; 35(10):1702-7

2. Spahn G et al. Four-Year Results From a Randomized Controlled Study of Knee Chondroplasty With Concomitant Medial Meniscectomy: Mechanical Debridement Versus RF Chondroplasty Arthroscopy 2010 Sept; 26(9):S73-S80

P/N 44333_A

* These articles have been selected from the full literature analysis due to their specific relevance to the discussed topics here

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Arthroscopic Evaluation of Radiofrequency Chondroplasty of the Knee

Hypothesis: Partial-thickness articular cartilage lesions treated with bipolar radiofrequency-based chondroplasty will show no progressive deterioration Methods: 193 consecutive patients underwent bipolar RF based chondroplasty over 38 months; 15 patients with 25 defects underwent repeat arthroscopy for recurrent or new injuries. Time from the initial to repeat arthroscopy ranged from 0.7 to 32.7 months. At both procedures, the location, size, grade, and stability of lesions were evaluated, recorded, and photographed arthroscopically. Results: At the initial procedure, 25 lesions treated ranged from 9 to 625mm2 (mean , 170.2±131.2mm2; median, 120mm2); at second look, lesion size was 9 to 300mm2 (mean , 107.7±106.7mm2; median, 100mm2). At second look, 3(12%) demonstrated unstable borders with damage in the surrounding cartilage that appeared progressive. Eight (32%) lesions were unchanged in size. Eight (32%) demonstrated partial filling with stable repair tissue, and 6 (24%) demonstrated complete filling with stable repair tissue. Lesions in the tibiofemoral compartments showed better response to radiofrequency chondroplasty than did those within the patellofemoral joint (P<0.05). Conclusion: Only 3 of 25 lesions demonstrated progression. More than 50% showed partial or complete filling of the defect. Bipolar radiofrequency chondroplasty is an effective way to treat partial-thickness cartilage lesions; however, long-term effects of this treatment on cartilage remain unknown. Study Limitations: • The only patients included in this study had symptoms sufficient to warrant

repeat arthroscopy. Thus this study group cannot truly represent the incidence of cartilage lesion progression in the original group of 193 patients because of obvious selection bias.

• The authors of the article performed the grading and size measurements of the lesions at the time of surgery.

• No biopsies of the repair tissue that filled the defects were performed, and the author can only speculate about i ts histologic nature.

• Data did not include functional outcomes of the patients in the study group.

A. Partial-thickness condral defect of the medial femoral condyle before bipolar radiofrequency-based chondroplasty.

B. After radiofrequency chondroplasty, the borders of the lesion are smooth and stable.

C. Fibrocartilage-like

tissue fi lling the previously treated lesion is observed on second look arthroscopy.

Voloshin I, et al. Am J Sports Med. 2007 Oct; 35(10):1702-7 Human In-Vivo Prospective ArthroCare Device

P/N 43140

Four-Year Results From a Randomized Controlled Study of Knee Chondroplasty With Concomitant Medial Meniscectomy: Mechanical Debridement Versus RF Chondroplasty

Spahn G et al. 2010 Sept; 26(9):S73-S80.

Purpose: Compare the effectiveness of simple mechanical debridement and 50°C controlled

bipolar chondroplasty. Methods: 60 patients with a medial meniscus tear and grade III defect of the medial femoral condyle were randomized assigned to receive one of the two treatments (30 per

group). All patients underwent partial or subtotal meniscectomy. Clinical outcomes were assessed using the Tegner score and Knee and Osteoarthritis Outcome Score (KOOS) assessment

Results: See figures at right.

Conclusion: Compared with classical mechanical debridement, bipolar RF currently appears to be the superior method for achieving a good midterm result. Further evaluations with long term follow-up are required

Study Limitations: • Only patients with Grade III articular cartilage lesions and concomitant medial

meniscus tears were studied. • Only the differences between MSD and RF treatment were studied with no real

control group. • 30% of the patients were lost to follow-up or required a second attempt at surgery.

Physical Activity level (Tegner Score). Before their illness , the patients had no difference in Tegner scores (P=.745). The disease related score decreased at the

time of operation in both groups(P=.63). At follow-up patients in the RFC Group had a significantly higher level of physical activity (P=.005)

Total N=60

Randomized 30 MSD Mechanical Shaving

30 – RFC RF Chondroplasty

At Four Year Follow Up

1 - Deceased

14-Required 2nd Surgery

15 – Remaining Group

1 – Lost to Follow up

4-Required 2nd Surgery

25 – Remaining Group

Preoperative Follow-Up 4 Yr

0

30

40

50

60

70

80

20

10

11.3 15.5

53.2

71.8 MSD

RFC

Both groups benefited from the operation. The pre-operative KOOS was 11.3 points in the MSD group, and 15.5 points in the RFC group (P=.279). Patients from

the MSD group had a KOOS of 53.2 points at follow up. In the RFC Group the KOOS(71.8) was significantly better(P<.0001)

KOO

S Sc

ore

Human In-Vivo Prospective, Randomized

ArthroCare Device

P/N 43140

Anterior horn lateral meniscus tear

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Anterior horn lateral meniscus tear;

adjacent to healthy ACL

Anterior horn lateral meniscus tear

debrided with shaver and Coblation wand

Parameniscal Cyst MRI – Coronal Sequence

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Parameniscal Cyst MRI – Axial Sequence

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Meniscus Tear – Hoop Stresses

Persistent cleft following shaver debridement of

meniscus tear with parameniscal cyst

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Meniscus Resection with Coblation Wand

s/p Coblation Treatment

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Chondroplasty

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Clinical Applications

Advancements in Coblation Technology for Treatment of Knee Pathology

March 5, 2014

Marty Isbell M.D.

Disclosure

Consultant for ArthroCare

Overview

• How I like to use the technology

• Clinical pearls

• Move beyond the shoulder and notchplasty

• Stimulate a healthy discussion

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Notchplasty

• Where most of us began using the technology in the knee

• Good place to start increasing your comfort level

• Applications of the technology are well beyond just this area

Meniscal Pathology

• Very useful for hard to reach places

• Anterior horn/Very far posterior horn

• Control bleeding at the root

• Can see what is going on at the tip of the device

Meniscal Pathology

• Really like it for the lateral meniscus • The 90 degree angle of the TurboVac • Debrides the edges of macerated tissue that often happens laterally • Intrameniscal cyst ablation

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Intrameniscal cyst

Chondroplasty

• Very useful device in this area

• Increasing frequency of use

• Like the appearance of chondroplasty better than that of a shaver

• Sealing the edges of the defect

Chondroplasty

• Good visualization of the tip

• Can watch the depth of penetration

• Paintbrush technique

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Chondroplasty

• Can use for concomitant procedures – synovectomy, lateral release

Chondroplasty

Chondroplasty

• Use it to clean and resect the edges of the defect

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Chondroplasty

• Not just for simple chondroplasty

• Second look defects – resect and debride bubbling/proud areas

Conclusions

• Useful technology for many types of knee pathology

• Move beyond notchplasty and simple chondroplasty

• Increase your comfort level – tough spots

• Using Coblation technology does not exclude you from performing additional treatments (ie. microfracture, ACI, or other cartilage procedures)

• Debridement of proud edges or areas of overfill

THANK YOU

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Thank You

P/N 56492 Rev. A