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.

Purpose

Describe the cartilage defects, patient characteristics, and clinical outcomes for adult patients treated with MACI^® (autologous cultured chondrocytes on porcine collagen membrane) for cartilage restoration to the patella.

Methods and Materials

Following institutional review board approval, data were collected for patients treated by 10 surgeons between Jan 2017 and Sep 2019. Patient demographics, cartilage defect characteristics, and concomitant surgical procedures were summarized with descriptive statistics. All patient demographics and cartilage defect characteristics were entered in the database although collection of final clinical and patient reported outcomes is ongoing.

Results

A total of 136 patients that received MACI treatment to the patella were available for analysis. The population was predominantly female (68%), mean age of 32 years, and BMI of 26.4 kg/m². A majority of patients had undergone multiple previous knee surgeries. The most common prior surgical procedures, aside from chondroplasty/abrasion arthroplasty done at the time of the cartilage biopsy, were cartilage debridement (65%), loose body removal (15%), and meniscectomy (13.2%).

The average MACI treated patellar defect was 4.6 cm². Approximately 20% of patients had a bipolar trochlear defect treated with MACI, and 17% of patients also had a MFC defect treated with MACI. The mean non-patella defect size was 4.4 cm². At the time of MACI implantation, 46% of patients had a concomitant tibial tubercle osteotomy and 32% underwent medial patellofemoral ligament repair/reconstruction.

Two patients where the largest treated defect was the patella were considered treatment failures due to graft failure and requirement for major revision (both patients received osteochondral allografts with concomitant TTO within 2 years of MACI surgery).

Conclusion

This is the first multicenter report of patient and cartilage defect characteristics for patients receiving MACI implantation in the patella. Clinical and patient-reported outcomes will be included in the final presentation.