A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee
Study for individuals suffering from knee pain and have been told their cartilage is injured, or suffer from mild to moderate knee arthritis or knee lesions.
Inclusion criteria: 21-75 years; Up to three treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea. Symptomatic total treatable area 1-7 cm2; Must be physically and mentally willing and able to comply with the postoperative rehabilitation protocol and scheduled clinical and radiographic visits. Signed and dated consent form. Non-responsive to physical therapy for at least three to four weeks.
Exclusion criteria: Malalignment more than eight degrees varus OR eight degrees valgus according to standing X-ray. Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure. Meniscal transplantation in the past six months. Any known tumor of the index knee. Any known history of intra-articular or osseous infection of the index knee.