Agili-C had better outcomes for osteochondral defects vs. debridement, microfracture
Key takeaways:
- An aragonite-based scaffold showed superior outcomes for osteochondral defects of the knee vs. the standard of care.
- The results reflect 4-year follow-up data.
SAN DIEGO — Use of an aragonite-based scaffold for the treatment of chondral or osteochondral defects of the knee had superior outcomes compared with debridement or microfracture at 4-year follow-up, according to results.
“It has been the relative ‘holy grail’ to find meaningful treatment for osteoarthritis. The challenging population of early osteoarthritis is even more difficult. Some of our conventional treatments, particularly when nonsurgical measures fail, such as cell-based repairs or bone and cartilage transplants, do not transfer when we start having joint space narrowing or multiple lesions,” Seth L. Sherman, MD, associate professor of orthopedic surgery at Stanford University, told Healio about results presented at the American Academy of Orthopaedic Surgeons Annual Meeting, here. “The intrigue of a scaffold like this that is off-the-shelf, acellular, relatively cost effective and fairly straightforward to do, if it can deliver outcomes for this difficult population without burning major bridges for possible future interventions, such as osteotomy or partial or total replacement, then I think it would be a real bonus for the community of us who deal with these difficult situations every day in our practices.”
Sherman and colleagues randomly assigned 251 patients with chondral or osteochondral defects in the knee to receive either a cell-free aragonite-based scaffold (Agili-C, Smith & Nephew) or the standard of care of debridement or microfracture.
The researchers collected patient-reported outcomes preoperatively and postoperatively at 6 months and annually up to 48 months after treatment. The change from baseline to 48 months in KOOS-Overall Rating was considered the primary endpoint and secondary endpoints included change from baseline in the Tegner Activity Scale; KOOS subscales; responder rate, defined as the percentage of patients achieving an increase in KOOS overall score of 30 points or more; and treatment failure rate.
In his presentation, Sherman said patients who had received the aragonite-based scaffold had superior KOOSoverall rating scores at 2 years, which was sustained throughout the 4-year timeframe. He said patients in the treatment group had superior Tegner scores that leveled off at 24 months and were sustained throughout the 4-year time period.
“[For] those patients who started out active vs. inactive, there was the same superiority and the same sustained results,” Sherman said in his presentation.
When stratified by age and BMI, patients in the treatment group had superior outcomes compared with the standard of care group, according to Sherman. He said the patients in the aragonite-based scaffold group had low rates of treatment failure compared with patients in the standard of care group.
“The 4-year data is quite reassuring that the results that we saw in the FDA study are extended out,” Sherman told Healio.
He added, “Continuing to carefully follow these outcomes overtime, looking at who might need injection therapy or other nonoperative treatment [and] who might go on to require other surgical interventions will help us to refine our indications for Agili-C for joint preservation.”
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Sherman SL, et al. Paper 2. Presented at: American Academy of Orthopaedic Surgeons Annual Meeting; March 10-14, 2025; San Diego.
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