Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects

Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.

The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant

Inclusion criteria

• 18 years or older
• Up to 3 treatable cartilage lesions, ICRS IIIa - IVb on the femoral condyles or the trochlea,
• Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
• KOOS Pain score at baseline is not less than 30 and not more than 65
• Must be physically and mentally willing and able to comply with post- operative rehabilitation protocol and scheduled clinical and radiographic visits.
• Informed consent signing

Exclusion criteria

• Bony defect depth deeper than 8mm, according to imaging Articular cartilage lesions in the tibia or the patella, ICRS grades IVa and IVb
• Any previous ligamentous repair or malalignment correction in the index knee within the last 3 months
• Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
• Lack of functional remaining meniscus
• Meniscal transplantation in the past 6 months
• Malalignment more than 5 degrees varus OR 5 degrees valgus according to standing X-ray
• Any known tumor of the index knee
• Any know history of infection of the index knee
• Any known history of inflammatory arthropathy or crystal-deposition arthropathy
• Any known systemic cartilage and/or bone disorder such as but not limited to chondrodysplasia or osteogenesis imperfecta
• Body mass index >35
• Osteoarthritis of the index knee graded as 4 according to the Kellgren- Lawrence scale
• Chemotherapy treatment in the past 12 months
• Any previous surgical cartilage treatment in the index knee within the last 6 months
• History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
• Patient who is pregnant or intends to become pregnant during the study
• History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare
• Known substance abuse or alcohol abuse
• Participation in other clinical trials within 30 days prior to the study or concurrent with the study
• Known insulin dependent diabetes mellitus
• Unable to undergo MRI or X-ray