Disclosures 8/11/2017. ACI 2 Stage Technique Generation 1. Technical Improvements and Expansion of Indications based on evidence for ACI
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1 Technical Improvements and Expansion of Indications based on evidence for ACI Tom Minas MD MS Director, Cartilage Repair Center, Brigham and Women s, Hospital, Professor, Harvard Medical School, Boston MA Disclosures Vericel ( formerly Genzyme Biosurgery) Consultant Elesevier Book royalties ConforMIS Inc., SAB member stocks and royalties ACI 2 Stage Technique Generation 1 Arthroscopic biopsy 2 nd stage open ACI Introducing the new era of Tissue Engineering, regenerative medicine and our Society ICRS 1
2 Landmark Paper The Beginning Brittberg M, Lindahl A, Nilsson A, Ohlsson C, Isaksson O, Peterson L. Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation. N Engl J Med. 1994;331(14): Femoral Condyles 14/16 G/E outcomes 2 revised Patella 2/7 G/E, 3 fair, 2 poor FDA BLA1233 August 1997 after review of 153 patients in Gothenberg, SW. Indications FC or trochlea, failed prior treatment, yrs. not indicated generalized OA, prior menisectomy, pediatric population or elderly > 65years old. Correction of the Background Factors Cause/contributing to chondral loss Biological Reconstructions Malalignment Status of meniscus Ligament stability Staged/simultaneous reconstruction Tasks ahead to expand care to our patients Technical improvements and Clinical Outcomes Patella Adolescents Multiple defects OA Insurance industry age restrictions, 18 45, 15 55? Complex reconstructions, ACL, HTO, DFO,meniscal transplant Prior cartilage surgery marrow stimulation, OCA Bony deficiency, uncontained defects Kissing defects PF, TF 2
3 Open Intraoperative Appearance Radical debridement to healthy margins, may require meniscal takedown for large posterior lesions medial meniscal takedown for long posterior MFC lesion and repair with transosseus sutures Adequate Debridement Healthy Cartilage margins with Pot Holes Technical considerations specific to the femoral condylar surface articulation 3
4 Technical considerations specific to the patellofemoral joint involve suture technique to restore the shape of the surface articulation ACI Multiple defects including; kissing lesions, patella trochlea and femur tibia) Suture technique to restore articular surface configuration ACI 6/21/1999 4
5 Post ACI X ray Post ACI MRI / Arthroscopy Hypertrophy of patellar graft / 3years post ACI Patella Outcomes Longterm Minas T, Bryant T. The role of autologous chondrocyte implantation in the patellofemoral joint. Clin Orthop Relat Res Jul; 436: Fulkerson Type III, IVa,b lesions do excellent with ACI von Keudell A, Han R, Bryant T, Minas T, Autologous Chondrocyte Implantation to Isolated Patella Cartilage Defects. Two to 15 Year Follow up. Cartilage, 1 9, 2016 Jul 30 patients 2 15 years, 83% G/E, 13% fair, 1 poor Fulkerson patella class 18 Type IV, 9 Type III,3 Type II, av 4.7cm sq MRI MOCART evaluation Fill grade, surface and integrity correlated with clinical scores 5
6 4 centers, 110 patients ( including bipolar) All scales, clinically & statistically sig improvements IKDC WOMAC Mod Cinc Activity % G/E 92% would do surgery again 8% (9) treatment failures 16% not improved Gomoll AH, Gillogly SD, Cole BJ, Farr J Minas T. Autologous chondrocyte implantation in the patella a multicenter experience. Am J Sports Med May;42(5): Survival rate was 84% at 5 years and 81% at 10 years Isolated Bipolar PF kissing lesions n= 60 Minas, Ogura, Bryant CRC BWH 2017 HJ # 141: 31 y.o. female Lateral Kissing LFC + LFC lesions to right knee. 6
7 2 Year 2 nd look ACI LFC+LTP+Lateral Meniscal Allograft HJ knees, av age 31.8, 7.9 yr F/U (2 16 year) Defect av 7.9cm2 (2.3 21) 17 lat MAT, 1 med 75% 5+10 yr survival g, y,, g g Chondrocyte Implantation and Meniscal Allograft Transplantation: Mid- to Long-term Outcomes. Orthop J Sports Med Oct 19;4(10): PERIOSTEAL COMPLICATIONS Hypertrophy 5 65 % in different studies Hypertrophy (Morphologic appearance) Superficial Fibrillation Edge Overlapping Onion layering Focal thickening (mounding) 7
8 Periosteal Substitute with Porcine Collagen Membrane USA ACI to MFC+LFC Disease progression 5 Yr ACI- Trochlea+Patella MM MFC+LFC CACI Type I III Collagen Porcine membrane Biogide MM 8
9 Multi center study, 3 centers 300P ACI vs 101 C ACI Compared 1 yr hypertrophy and failure rates Similar age #defects C>P 1.8 to 1.5 (P=0.001) overall SA C>P, 8.6 to 6.7cm2 (p=0.003) 25.7% P 5% C hypertrophy requiring scope (p<0.0001) 2.3% P vs 4%C failed (p=0.2) 1. Gomoll AH, Probst C, Farr J, Cole BJ, Minas T. Use of a type I/III bilayer collagen membrane decreases reoperation rates for symptomatic hypertrophy after autologous chondrocyte implantation. Am J Sports Med Nov;37 Suppl 1:20S-23S. Epub 2009 Oct 19. PubMed PMID: pts< 18 YO, av 15.9 YO F/U 2 19yrs, av 9.6yrs Av SA 6.2 cm sq, (2 23.4cm sq) 5&10 survivorship 89% +20 yr K M 90% G/E, 96% would choose surgery again No change in Kellgren Scores no OA 1. Ogura T, Bryant T, Minas T. Long-term Outcome of Autologous Chondrocyte Implantation in Adolescent Patients. Am J Sports Med Apr;45(5): doi: / Epub 2017 Jan 27.PMID: PTS > 45 yo ( 45 60) F/U 4.7 yrs, 2 11 yrs TSA 9.8 cm sq, ( cm sq) 72% G/E, 88% improved,81% choose surgery again 8 failures(14%); 6 WC, 2 non WC Without WC 2/48= 4% failed=96% success Rosenberger RE, Gomoll AH, Bryant T, Minas T. Repair of large chondral defects of the knee with autologous chondrocyte implantation in patients 45 years or older. Am J Sports Med Dec;36(12): Epub 2008 Aug 25. 9
10 138 patients, 2 11 yrs Av age 38.3 yrs, early OA Av SA 10.4 cm sq/knee 5 yrs P/O 92% functioning well 75% improvement in WOMAC scores` 8% Failure to TKA Minas T, Gomoll AH, Solhpour S, Rosenberger R, Probst C, Bryant T. Autologous chondrocyte implantation for joint preservation in patients with early osteoarthritis. Clin Orthop Relat Res Jan;468(1): primary ACL+ ACI 6.6 cm2 13 rev ACL+ACI 10.3 cm2 Same outcomes (nsd) Mod Cinc Knee VAS , WOMAC /26 failed 69% improved, 92% surgery again Pike A, Bryant T, Ogura T, Minas T. Intermediate to Long-term Results of Combined Anterior Cruciate Ligament Reconstruction and Autologous Chondrocyte Implantation Orthop J Sports Med Feb 24;5(2): ecollection 2017 Feb. PMID: PMCID: 325 consecutive joints 111 MST vs 214 virgin chondral defects Failure rate 26% vs 8%, > 3x 5X failure rate after prior MFX Nawaz SZ, Bentley G, Briggs TWR, et al. Autologous Chondrocyte Implantation in the Knee.Mid-Term to Long- Term Results. JBJS (Am.)96:824-30, % failure rate at 10 years after prior cartilage repair Leela C. Biant, George Bentley, Sridhar Vijayan, John A. Skinner and Richard W.J. Carrington. Long-term Results of Autologous Chondrocyte Implantation in the Knee for Chronic Chondral and Osteochondral Defects. Am J Sports Med : Originally published online July 7, Failures 7/28 in ACI prior MFX versus 1/28 ACI = 6x failure rate Pestka JM,et al..clinical Outcome of Autologous Chondrocyte Implantation for Failed Microfracture Treatment for Articular Cartilage Defects in the Knee.Am J Sports Med.2012 Feb;40(2): Minas T, Gomoll AH, Rosenberger R, Royce RO, Bryant T. Increased failure rate of autologous chondrocyte implantation after previous treatment with marrow stimulation techniques. Am J Sports Med
11 Contained Osteochondral Defect Osteochondritis Dissecans Avascular Necrosis(Idiopathic) Bone cysts Failed Osteochondral allografts/autografts Failed Synthetic plugs Sandwich ACI Defect Preparation Sandwich ACI versus ABG alone 24 ACI Sandwich patients vs 17 ABG patients (Follow up Avg = 7.8 yrs vs 15.7 yrs) Minas, Ogura, Hendrick, Bryant CRC BWH
12 23 YO male MSU Football player HX Right knee injury OATS MFC MFX MFC allograft MFC arthroscopic debridement trochlea defect, extension of disease around allograft Presently, 8/10 pain with walking, biking, getting out of bed first steps Sports not possible Standing Xrays Extensile exposure TTO (+/ HTO) 12
13 Intraoperative Findings Debridement and Cyst removed with hi speed Burr 13
14 Post op xrays 6 month Post op MRI MFC ACI Sandwich LFC ACI 14
15 One Year Post operative Presently Generation 1+ Collagen Membrane Treat background factors and collagen membrane resurfacing Remain aggressive and successful >90% G/E 49YO Male HTO_TTO ACI_MFC_MTP_LFC_Troch 4 years Post op hiking in the Alps years post op 15
16 Bipolar ACI T F Outcomes N= 58 knees, 56 patients, medial 32, lateral 26 TSA 16.1 cm sq ( Range cmsq) F/U 8.3yrs (2 20), Survivorship Overall 80% 5yr and 76% 10yr Collagen membrane 5 yrs vs > Periosteum 61%, p=0.001 Minas, Ogura,Mosier Bryant CRC BWH patients(24 knees) > 20 yr follow up 2.1 defects/knee, TSA av 11.8 cm sq ( cm sq) 20 yr survival 63% Excellent outcomes 20 yrs later 79% maintained their native knees and were satisfied p Based Cartilage Products NeoCart, NOVOCART, and MACI Cartilage Tissue Implant Cells Embedded in Membrane Cells on the Surface of Membrane Autologous chondrocytes are seeded in a bovine-derived three-dimensional type I collagen honeycomb matrix The chondrocyte-embedded matrix is then cultured in a bioreactor, which creates an environment of variable hydrostatic pressure and low oxygen tension, to simulate intraarticular conditions NOVOCART 3D is a combination of autologous chondrocytes and a biphasic, three-dimensional collagen-chondroitin sulphate scaffold Cultured Cells embedded into the scaffold Matrix: three-dimensional, biphasic collagenchondroitin sulphate scaffold. Cultivation time: 2-3 weeks from cartilage harvest MACI, autologous cultured chondrocytes on porcine collagen membrane, is a cellular sheet that consists of autologous chondrocytes seeded on a 3 x 5 cm, resorbable porcine Type I/III collagen membrane, for implantation into cartilage defects of the knee. The active ingredients of MACI are the autologous cultured chondrocytes and porcine Type I/III collagen. BM: bone marrow; NA: not applicable; P1: passage 1: PEG, polyethylene glycol. Huang BJ, et al. Biomaterials. 2016;98:
17 MACI Vericel,Inc., FDA approved Dec. 13, YO Male,failed MFX VMO adv+lat release Jan Biologic Reconstruction Summary Background factors critical Alignment, tracking, stability, meniscus Realistic patient Informed consent risks and recovery Surgeon knowledge of outcomes and skill factor 17
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