Clinical Outcome

P213 - 5 year follow up data of patients treated with GelrinC reveal substantial and sustainable pain and symptom relief.

Abstract

Purpose

To assess the long-term effectiveness and sustainability of GelrinC in the treatment of articular cartilage repair injuries.

Methods and Materials

A total of 52 patients were successfully treated with GelrinC and followed up at specific timepoints, up to 5 years. The clinical study enrollment criteria included patients within the age range 18-65, with 1-6 cm2 ICRS grade III to IVA lesions to the femoral condyle. Clinical effectiveness was measured by Patient Reported Outcome questionnaires whereas the quality of the regenerated cartilage was evaluated by MOCART and T2 mapping up to 24 months following treatment. A subgroup analysis was performed to assess the effect of GelrinC treatment for Chondral and Osteochondral lesions as well as for patients who were treated secondary to a failed cartilage repair procedure.

Results

The clinical results reveal a substantial and significant (p<0.001) improvement in all KOOS sub-scales with maximum improvement of 44.7±5.6 points in KOOS Sports/Rec at 4 years (N=22) and similar improvement of 42.2±7.0 points at 5 years (N=18) compared to baseline. Moreover, patients reported the maximum improvement in KOOS Pain (33.74±3.9 points) and KOOS ADL (33.5±4.0 points) at 4 years (N=22) with similar change of 32.69±5.0 points and 32.2±3.9 points in KOOS Pain and ADL respectively 5 years following treatment (N=18). The subgroup analysis confirms that the outcomes of patients treated with GelrinC following a failed cartilage repair procedure are as good as those treated with GelrinC as a primary treatment. Also, the MOCART scores after 24 months (88.8±1.5) demonstrate similar high-quality cartilage formation in both Chondral and Osteochondral lesion groups.

Conclusion

GelrinC is a promising treatment option offering long-term and sustainable pain and symptom relief for patients. Furthermore, GelrinC is an excellent treatment option for patients undergoing primary treatment and for patients who failed previous cartilage repair procedures.

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