Joint Preservation Clinical Case

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1 Joint Preservation Clinical Case Jason M. Scopp, M.D. Director of Joint Preservation Peninsula Orthopaedic Associates, 1/19/19

2 Rational Rationale There are no absolutes. There is no dogma. Organize thoughts, understand options, outcomes.

3 Let s set a machine to: Sept 17, 2019

4 Patient 53 of the day 23 y old State Trooper with knee pain and swelling.

5 Surgical History 2006: Dr. X performed hamstring autograft RIGHT knee. Never did PT, went back to soccer 6m post-op 2009: Tore LEFT ACL, reconstruction at POA

6 Surgical History 2011: Sports injury at SU, RIGHT knee Re-tear lateral meniscus Chondral changes to LFC 2012: Re-tore LEFT ACL at SU Revised uneventfully

7 Surgical History 9/2017: Work injury to RIGHT knee MRI Bone bruise LFC, ACL intact Treated non-op 3/2018: ORIF LEFT fibula 8/2018: continued RIGHT knee pain

8 Diagnostics

9 Diagnostics

10 Fellows: What would you do now? BTW: You are an hour behind and your spouse just texted you

11 Summarize data and make a plan What do we know and what is next step?

12 If you go to a barber, you get a haircut Arthroscopy is also a diagnostic tool

13 ACL is intact

14

15

16 Post op visit 1 How do you council this patient? Any additional diagnostics? How do you organize your thoughts for a complex patient?

17

18

19 Problem List 1. Lateral meniscus deficient 2. Chondral defect LFC 3. Chondral defect LTP 4. Valgus 5. Work comp 6. Expectations/ compliance

20 Joint Stability Scaffold Functional Unit of the Knee Macroscopic Cartilage Microscopic Chondrocytes

21 My surgical plan MACI LFC Lateral MAT Double bone plug Distal femoral osteotomy

22 Pre-Operative Planning Midpoint of lateral plateau vs. Between the spines Mechanical Axis

23

24 Case Order 1. The approach -Swashbuckler incision Starr AJ et al. JOT. February Volume 13 - Issue 2 pp: Defect prep 2. Osteotomy 3. Implant lesion

25

26

27 Distal Femoral Osteotomy Pre-Osteotomy Alignment After-Osteotomy Alignent

28 Distal Femoral Osteotomy

29 Diagnostic Scope

30 Prep Knee

31 Prep Graft

32 Medial Notchplasty to View Posteromedial

33 Posterior Tunnel with Flip Cutter

34 Passing the Meniscus

35 Posterior Tunnel Clear Soft Tissues

36 Introduce Meniscus

37 Meniscus Fixation

38 Anterior is drilled under direct visualization

39

40 Complications Arthrofibrosis Meniscal Detachment Meniscal Shrinkage Meniscal Failure Meniscal Extrusion

41 Pitfalls and Pearls Appropriate Surgical Planning Don t Compromise Exposure Adequate Fixation Techniques Presence of Meniscal Remnant Accurate Positioning of Bone Anterior Horn Fixation Placement of Pull-Through Suture

42 Rehabilitation Early Protected WB; Full WB at 4-6 weeks Limited Early Motion Similar to Delayed Meniscal Repair Use of Unloader Brace Early Treatment of Concerns

43 Concomitant Procedures Alignment Ligament Reconstruction Joint Resurfacing

44 Asymptomatic Post-Menisectomy Knee Education about signs and symptoms of knee degeneration 45-degree PA radiographs MRI Articular cartilage tends to rapidly break down, especially in lateral compartment Younger patient strongly consider early intervention

45 Cartilage Treatment Options Multiple options for small, focal lesions

46 Cartilage Treatment Options Limited options for large, multifocal lesions or lesions of the patellofemoral joint

47 ACI can bridge these gaps Complex Grade III-IV chondral lesions Large condyle or trochlea lesions Patella lesions (off label)

48 ACI can bridge these gaps Complex Grade III-IV chondral lesions Bipolar Multifocal (MFC, trochlea)

49 Prospective Clinical Trial in Clinical Trial Medial Condyle- 102 Lateral Condyle- 27 Trochlea- 24 OCD- 40 Kaplan-Meier representation of Dura Zaslav K, et al. Am J Sports Med. 2009;37:42-55 Please see additional Important Safety Information for CARTICEL (autologous cultured chondrocytes) on slide 4 of this presentation. Please see Full Prescribing Information from your Sanofi Biosurgery representative. US.CAR

50 Overall Modified Cincinnati Knee Scores Improved with CARTICEL Improvement in Overall Modified Cincinnati Knee Score from Baseline to 48 Months Baseline (n = 154) 48 months (n = 115) Poor (1-2) Fair (3-4) Good (5-6) Very Good (7-8) Excellent (9-10) 28% 60% 12% 0% 0% 7% 16% 29% 31% 17% At baseline, the majority of patients had poor to fair scores (88%) 48 months after treatment, the majority (77%) of patients had good to excellent scores Zaslav K, et al. Am J Sports Med. 2009;37: Important Safety Information for CARTICEL : The occurrence of subsequent surgical procedures (SSPs), primarily arthroscopy, following CARTICEL implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to CARTICEL, during the 4-year follow up. Please see additional Important Safety Information for CARTICEL (autologous cultured chondrocytes) on slide 4 of this presentation. Please see Full Prescribing Information from your Sanofi Biosurgery representative. US.CAR

51 KOOS Subscales Improved with CARTICEL Statistically significant improvements in all KOOS domains Baseline (SD) 12 months (SD) 48 months* (SD) Pain 48.7 (16.1) (n=153) 67.0 (20.3) (n=147) 72.2 (20.4) (n=115) KOOS Mean Scores Other Symptoms 51.8 (19.0) (n=154) 66.9 (18.4) (n=147) 70.8 (18.8) (n=115) Sports ADLs Knee QOL 25.8 (24.0) (n=141) 44.0 (26.5) (n=134) 55.8 (29.3) (n=110) 0 is worst possible score and 100 is best possible score. Other symptoms include clicking, popping and locking, ADLs = activities of daily living, QOL = quality of life Evaluable patients at each reported time point were those who completed follow-up without surgical treatment failure (19.6) (n=152) 76.0 (19.7) (n=147) 81.0 (19.0) (n=115) 20.9 (15.2) (n=154) 38.6 (21.6) (n=147) 52.2 (25.1) (n=115) * P<0.001 from baseline to 48 months Zaslav K, et al. Am J Sports Med. 2009;37: Important Safety Information for CARTICEL: CARTICEL is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL. Please see additional Important Safety Information for CARTICEL (autologous cultured chondrocytes) on slide 4 of this presentation. Please see Full Prescribing Information from your Sanofi Biosurgery representative. US.CAR

52 Autologous Chondrocyte Implantation (ACI) Three Generations Third Generation- Cells seeded onto the Collagen Mem First Generation- Cells with Periosteum Second Generation- Cells with Collagen Membrane C

53 Cell-based technologies Chondro-Gide/Geistlich Cultured AC added Wait 10 minutes for adherence Chondro-Gide Su Matthias Steinwachs: Technique Paper: Arthroscopic and Related Surg- Vol

54 Step One: Arthroscopic Assessment Biopsy Technique Intercondylar notch Prox./sup. to sulcus terminalis 5x10mm, mg

55 Step Two: Cell Implantation Approach by defect location and other procedures Outline defect; include all soft/fissured cartilage Create stable vertical shoulders

56 Step Two: Cell Implantation Template defect with glove paper or aluminum foil Seed Membrane (optional step) Place sized membrane on defect, trim

57 Step Two: Cell Implantation Secure with multiple interrupted 6-0 sutures Waterproof suture-line with fibrin glue Inject cells and close injection site

58 82 Studies >3000 patients Failure Rate- 7.7% Re-operation rate-36% ACI Complications

59 ACI Complications Unplanned re-operation 27% ACI using periosteum 5% ACI using collagen cover Majority of Failures occurred within the first two years post-implantation

60 Swedish Outcomes 224 patients- 10 to 20 yr follow-up: 5.3cm 2 74% Good Result- 92% patient satisfaction

61 Brigham and Women s Outcome Complex and Salvage Cases: 210 Patients with 10 to 20 Year Follow-up 8.4cm 2 75% of patients good outcomes> 10 yr

62 2 nd Look Scopes 4 years Post Implant

63 Special Considerations Correct Alignment to optimize outcome Especially true for patella lesions Early results 28% G/E vs % with correction of malalignment

64 The SUMMIT STUDY Matrix Applied Characterized Autologous Chondrcyte Implants (MACI) vs. Microfracture; A Prospective, Randomized Trial in European Patients, 2-Year Follow Up 64

65 MACI ACI-Maix is the brand name of Matricel s CE Marked collagen scaffold for articular cartilage regeneration. It has been used clinically since 2002 mainly for the repair of traumatic cartilage defects with cells seeded on the membrane. More than patients have been accessed 31/3/14

66 KOOS Response Rate (%) More MACI Patients Responded to Treatment 86.1 P= Response to treatment > 10 point improvement in both Pain AND Function 66 MACI EPAR EMA/CHMP/25287/2013

67 Joint Stability Scaffold Functional Unit of the Knee Macroscopic Cartilage Microscopic Chondrocytes

68 The patients who do well are the patients who are selected well Daniel Saris ICRS 2015

69 Some advice: Avoid VOMIT: Victim Of Modern Imaging Technology BARF: Blind Application of Radiographic Findings Linear thinking A B

70 Symbiotic Relationship of Meniscus and Articular Cartilage Concept of a Functional Unit

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