Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe

Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe

The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.

Agili-C™ implant is a CE marked. The Agili-CTM implant is a 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
• Osteoarthritis of the First Metatarsophalangeal Joint
• Presence of good bone stock
• Physically and mentally willing and able to comply with post-operative
• rehabilitation and routinely scheduled clinical and radiographic visits

Exclusion Criteria:

• < 18 years of age
• Any past or present evidence of infection of the treated joint
• Any known malignant tumor of the foot
• Known inflammatory arthropathy or crystal-deposition arthropathy
• Chemotherapy treatment in the past 12 months
• History of allergic reaction or intolerance to 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 in parallel to this study
• Known insulin dependent diabetes mellitus
• Unable to undergo imaging studies