Purpose

The Agili-C implant has shown to provide early and predictable knee joint regeneration (1). The repair process appears to involve stem cell recruitment and repair of both subchondral bone and articular cartilage (2).

1. Kon, E. et al., A novel aragonite-based scaffold for osteochondral regeneration: early experience on human implants and technical developments. Injury, 2016. 47 Suppl 6: p. S27-S32.

2. Kon, E. et al., Osteochondral regeneration using a novel aragonite-hyaluronate bi-phasic scaffold in a goat model. Knee Surg Sports Traumatol Arthrosc, 2014. 22(6): p. 1452-64.

Methods and Materials

12 Subjects, recruited as part of a 24-month, multi-center Agili-C implant performance study (143 Subject cohort), were evaluated at baseline and at least annually for 48 months. The Subjects filled out KOOS and IKDC questionnaires, as well as performed an annual MRI of the index knee.

Results

Average age was 35±6.3 (9M, 3F). Defect location was on the Medial condyle (7 subjects) and Lateral condyle (5 subjects). Implant diameter was 10mm in 5 cases, 14mm in 3 cases, 17mm in 2 cases and 20mm in one case.

Average overall KOOS score was 38±15 and the KOOS pain subscale was 49±15 at baseline, improving to 83±10 and 74±11 at 12 months, 86±14.6 and 79±15 at 24 months, 88±11.5 and 83±15 at 36 months, 86±17 and 82±18.5 at 48 months.

Conclusion

A medium term (48 month) follow-up of the Agili-C indicates that there is no deterioration of the repaired tissue during this period. Knee function remains close to the general population-average, supporting the histological results obtained in goats, indicating restoration of hyaline cartilage and normal subchondral bone [2]. The repair reaction induced by the Agili-C implant appears to preserve knee joint function and to provide consistent pain relief.