16.2.2 - Aragonite-Based Scaffold Provides Superior Clinical Outcome Compared to Debridement/Microfracture: Multi-Center, RCT
- A. Gomoll (New York, US)
- A. Gomoll (New York, US)
- S. Strickland (New York City, US)
- K. Zaslav (New York, US)
- V. Dasa (LA, US)
- E. Kon (Milano, IT)
- D. Robinson (PetahTikwa, IL)
- G. Morag (Ramat Gan, IL)
- N. Altschuler (Kfar Saba, IL)
Abstract
Purpose
The objective of this multicenter, randomized and controlled trial was to compare the outcome of patients affected by joint surface lesions (JSLs), with or without concurrent OA, treated with an aragonite-based osteochondral implant (Agili-C™, CartiHeal Ltd, Israel) to a control group, treated with arthroscopic debridement/microfracture.
Methods and Materials
251 subjects were enrolled in 26 medical centers, according to the following criteria : 1) age 21–75 years; 2) up to three JSLs, ICRS Grade IIIa or above, located on the femoral condyles and/or trochlea; 3) total treatable area from 1 to 7 cm2 ; 4) bony defect depth less than 8mm; 5) knee OA grade 0-3 according to Kellgren-Lawrence score. Subjects were randomized to the implant or debridement/microfracture in a 2:1 ratio. Evaluation was performed at 6,12,18 and 24 months, based on: KOOS (primary endpoint), IKDC-subjective, Tegner and SF-12 questionnaires. Subjects also underwent MRI evaluation at 12 and 24 months to assess defect fill. Failures (i.e. need for any secondary treatment) and adverse events were recorded.
Results
Both groups presented comparable demographic characteristics and baseline values. The implant group showed statistically superior outcome in the primary endpoint and all secondary endpoints at all follow-up visits. The magnitude of improvement in the implant group was twice as large than the control group in terms of mean KOOS improvement. Similar results were documented in all other scores recorded. Responder rate (defined a priori as at least 30-points improvement in KOOS) was 77.8% in the implant group compared to only 33.6% in the control (p<0.0001). At 24 months, 88.5% of the implanted subjects had at least 75% defect fill on MRI compared to 30.9% of subjects treated with debridement/microfracture (p<0.0001). Failure rate was 7.2% for the implant group vs 21.4% for control.
Conclusion
The aragonite-based implant provided superior clinical and radiographic outcome compared to debridement/microfractures at 24 month evaluation.