30 Patients with Early Osteoarthritis Treated with Agili-C Implant: Clinical outcomes up to 24 months post-surgery
Purpose: The clinical outcome following implantation of Agili-CTM implant (CartiHeal) implant in patients with early osteoarthritis.
Materials and Methods: 30 Patients with mild to moderate osteoarthritis (Kellgren-Lawrence II and III according to X-ray at baseline) were treated with Agili-C implant. Inclusion criteria: presence of an articular surface lesion ICRS grade 3 or 4, up to 6 cm2 total treated area. Exclusion criteria: K-L Grade IV, inflammatory arthritis and septic joint. Study endpoints included Overall KOOS score (average of all KOOS subscales), KOOS Pain, as well as sequential MRI scans.
Results: 30 patients were evaluated in this ongoing study. Currently data from 21 patients is available at 6 months follow-up, 15 patients at 12 months and 10 patients at 24 months. Overall KOOS improved from 44.8±14.1 at baseline to 63.8 ± 20.2 at 6 months, 75.5±17.6 at 12 months and 81.7± 18.7 at 24 months. KOOS Pain subscale improved from 54.4±15.7 at baseline to 75.0±22.3 at 6 months, 83.5±15.3 at 12 months and 86.7±15.5 at 24 months.
Discussion: To date, most cartilage repair studies treat isolated, focal, knee cartilage defects, while the more common degenerative cartilage defects are often excluded. Interim analysis of this cohort group indicates that the Agili-CTM implant may provide a viable treatment for patients with mild to moderate osteoarthritis. The implant replaces the cartilage and its underlying subchondral bone and thus may contribute to the positive clinical results, even in osteoarthritic joint conditions.