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Off-label use of a collagen membrane for ACI in United States shows decreased hypertrophy

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MIAMI -- U.S. researchers have shown that performing autologous chondrocyte implantation (ACI) with a collagen membrane approved for dental procedures leads to statistically significant lower reoperation rates for hypertrophy-related issues than ACI with a periosteum.

To avoid periosteal hypertrophy, European surgeons have, for some time, switched to using collagen membranes in ACI. However, no U.S. Food and Drug Administration-approved collagen membrane exists for this indication.

“Our research confirmed prior reports from Europe, which has an official collagen membrane for that indication,” Andreas H. Gomoll, MD, said during his presentation at the 8th World Congress of the International Cartilage Repair Society, here. “We found that it dramatically lowers the reoperation rate from 52% to 6%, and there was no difference in the failure rate in the first year.”

Gomoll and his colleagues compared the results of their last periosteal ACI procedures performed in 100 patients with the outcomes of 54 patients who underwent ACI using a Type I/III bilayer porcine collagen membrane (BioGide, Geistlich Pharma) and had a minimum 1-year follow-up.

The investigators used reoperation within the first year for cover-related issues as their primary endpoint, and failure within the first year as a secondary endpoint.

The investigators discovered a 6% reoperation rate in the collagen membrane group compared to a 52% rate in the periosteal group. They also found one failure in each group within the first year.

Reference:

• Gomoll A, Probst C, Bryant T, et al. Decreased surgical re-intervention rate for hypertrophy after ACI with use of the BioGide collagen membrane. Paper #15.3.3. Presented at the 8th World Congress of the International Cartilage Repair Society. May 23-26, 2009. Miami.