Abstract
Objectives:
Chondrofix® is a pre-shaped cylindrical, decellularized and sterilized osteochondral allograft (OCA). The purpose of this study was to evaluate functional outcomes and graft survivorship among patients treated with this implant for cartilage injuries in the knee.
Methods:
An IRB-approved database was used to identify a prospective series of 32 patients who had been treated with the Chondrofix implant. The surgeries were performed in two centers by two surgeons. The mean age ± Standard Deviation (SD) of the patients was 35.1 ± 10.6 years; 59% were male. Twenty-four (75%) knees had previous surgery. The mean defect area ± SD was 2.9 ± 2.0 cm² . The mean allograft size ± SD was 13.18 ± 2.3 mm (6 grafts ≤ 9 mm and 59 grafts ≥11mm). The number and type of reoperations were assessed. Failure was defined as structural damage of the graft diagnosed by arthroscopy or magnetic resonance imaging and any reoperation resulting in removal of the allograft. Patients were evaluated pre- and postoperatively using the Knee Injury and Osteoarthritis Outcome Score (KOOS) scale and Marx Sports Activity Scale.
Results:
Twenty-three of the 32 knees (72%) were considered failures, and 14 of the 32 knees (43%) had further surgery following the index procedure. Implant survivorship was 19.6% at 2 years(Graphic). The mean follow-up duration was 1.29 years (range 0.11- 2.8 years). KOOS Pain, ADL, Sports and Knee-related Quality of Life (QOL) improved significantly from the preoperative visit to latest follow-up (Table). Age was significantly predictive of failure with hazard ratio of 1.68 per 1SD older (95% CI, 1.05 to 2.68, p = 0.030).
Conclusion:
The decellularized and sterile osteochondral allograft implant demonstrated a 72% failure rate within the first 2 years of implantation in these two institutions.