Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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