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

Study Overview
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Brief Summary
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Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.

Detailed Description
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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

Official Title
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Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD)

Conditions
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Cartilage or Osteochondral Defects in the Knee

Intervention / Treatment
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* Device: Agili-C™ implantation procedure


Participation Criteria
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Eligibility Criteria
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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

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 C™<br>Candidates will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study. | Device: Agili-C™ implantation procedure<br>* Candidates for Agili-C™ implantation will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • The KOOS Pain Subscale relative to baseline | The KOOS pain subscale is evaluated at 6m, 12m, 18m & 24m | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Improvement in other KOOS subscales relative to baseline | Other KOOS subscales are evaluated at 6m, 12m, 18m & 24m | 24 Months | 
| • Improvement in IKDC Subjective Knee Score relative to baseline | IKDC Subjective Knee Score is evaluated at 6m, 12m, 18m & 24m | 24 Months | 
| • Improvement in SF-36 Survey | SF-36 Survey is evaluated at 6m, 12m, 18m & 24m | 24 Months | 
| • Improvement in Tegner Score | Tegner Score is evaluated at 6m, 12m, 18m & 24m | 24 Months | 
| • Improvement in Lysholm Knee Scoring Scale | Lysholm Knee Scoring Scale is evaluated at 6m, 12m, 18m & 24m | 24 Months | 
| • Joint Space maintenance rate according to X-ray | Joint Space maintenance rate is evaluated at 12m & 24m | 24 Months | 
| • Defect Fill according to MRI | Defect Fill according to MRI is evaluated at 6m, 12m, 18m & 24m | 24 Months | 
| Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline | The KOOS Overall is evaluated at 6, 12,18 & 24 months | 24 mMonths |