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One-stage procedure for cell-based cartilage repair successful in multicenter trials

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MANCHESTER — Researchers from Europe and the United States reported good minimum 1-year results with the Cartilage Autograft Implantation System (CAIS) for repairing articular cartilage lesions of the knee.

CAIS (DePuy Mitek) involves preparation and delivery of mechanically morselized, autologous cartilage uniformly dispersed on a 3-dimensional, bioabsorbable scaffold, and fixated in the defect with bio-absorbable staples. noted lead investigator Tim Spalding, FRCS, of Coventry, England, who presented the early results at the British Orthopaedic Association Annual Congress 2009.

“The mechanical fragmentation of cartilage tissue maintains chondrocyte viability and creates increased surface area, which facilitates the outgrowth of embedded chondrocytes onto the scaffold,” he said.

The European Union pilot clinical study involved 25 patients from five countries randomized in a 2:1 schema (CAIS:microfracture). The mean age was 35 years (range, 22-51) and included 14 men and 11 women.

Subjects returned for follow-up visits at 1 and 3 weeks, and at 2, 3, 6, 9 and 12 months. Subjects were clinically evaluated and interviewed for the occurrence of adverse events and asked to complete clinical outcome questionnaires, including the Knee Injury and Osteoarthritis Outcome Score (KOOS) regarding disability, function, pain and quality of life.

Researchers also conducted a U.S. pilot clinical study on 29 patients treated with CAIS. This multicenter study involved five sites, and the study parameters were similar to those of the E.U. trial, according to the abstract.

Spalding said the harvesting device and instrumentation “enabled the successful preparation and fixation of viable morselized autologous cartilage tissue loaded implants in a single intraoperative setting. Also, there were no safety issues to report” in either study arm.

KOOS outcome scores at 12 months for the E.U. trial and 18 months for the U.S. arm improved from baseline in both studies and were comparable to microfracture. he added.

“This pilot study of a novel device for one-stage cell based cartilage repair shows CAIS to be safe and comparable to microfracture and forms the basis of ongoing pivotal studies,” he said.

Reference:

• Spalding T, Almqvist F, Brittberg M, et al. The CAIS project: European multicentre randomised controlled pilot study of a one-stage procedure for cell-based cartilage repair. Presented at the British Orthopaedic Congress Annual Congress 2009. Manchester.