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

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

Detailed Description
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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.

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

Conditions
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Osteoarthritis of Multiple Joints of Ankle or Foot

Intervention / Treatment
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* Device: Agili-CTM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Agili-CTM<br>Intervention | Device: Agili-CTM<br>* Consenting individuals will be selected from the population of patients with osteoarthritis of the great toe examined by a participating investigator. Following signing an informed consent, candidates will be evaluated by an adjudication committee for possible inclusion in the trial based on medical history and Standing Foot X-ray. Candidates that are approved or conditionally approved by the adjudication committee will undergo Agili-CTM implantation procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot and Ankle Ability Measure (FAAM) score | FAAM score will be evaluated at 24 months compared to baseline | 24 month | 
| Visual Analog Scale (VAS) Pain | VAS will be evaluated at 24 months compared to baseline | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Great toe range of motion | Great toe range of motion will be evaluated at 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months compared to baseline | 2 weeks, 6 weeks, 3, 6, 12 18 and 24 months | 
| Pain according to Visual Analog Scale (VAS) | VAS score will be evaluated at 2 weeks, 6 weeks, 3, 6, 12 and 18 months | 2 weeks, 6 weeks, 3, 6, 12 and 18 months | 
| Activities of Daily Living Subscale according to Foot and Ankle Ability Measure (FAAM) | FAAM score will be evaluated at 2 weeks, 6 weeks, 3, 6, 12 and 18 months | 2 weeks, 6 weeks, 3, 6, 12 and 18 months | 
| AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society-AOFAS) | AOFAS will be evaluated at 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months compared to baseline | 2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months | 
| Measurament of Joint Space maintenance in mm | Joint Space maintenance will be evaluated at 12, and 24 months compared to baseline | 12 and 24 months | 
| Quality of life questionnaire (SF-36) | SF-36 will be evaluated at 6,12, 18 and 24 months compared to baseline | 6, 12, 18 and 24 months |