Agili-C™ Implant Performance Evaluation

Study Overview
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Brief Summary
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The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.

Detailed Description
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This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™ vs. SSOC for the repair of joint surface lesions. Follow-up visits will be performed at 2 weeks and at 3, 6, 12, 18 and 24 months post-procedure to evaluate the patient's knee condition and clinical health. The following questionnaires: KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation , SF-12 Health Survey, Tegner Activity Score will be completed at baseline and at 6, 12, 18 and 24 months. Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at 6, 12, 18 and 24 months post procedure. MRI according to specific protocol will be performed at 12 and 24 months.

Official Title
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A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee

Conditions
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Cartilage or Osteochondral Defects in the Knee, Up to Moderate Osteoarthritis

Intervention / Treatment
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* Device: Agili-C implant
* Procedure: SSOC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 -75 years Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable) Non-responsive to physical therapy for at least 3-4 weeks Exclusion Criteria: KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100) Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal) Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure Meniscal transplantation in the past 6 months Any known tumor of the index knee Any known history of intra-articular or osseous infection of the index knee Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other) Any known history of inflammatory arthropathy or crystal-deposition arthropathy Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta Body Mass Index (BMI) > 35 Chemotherapy in the past 12 months Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in the index knee within the last 6 months Any previous ligamentous repair or malalignment correction 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, hepatitis, HTLV, syphilis, and coagulopathies Known substance or alcohol abuse Participation in other clinical trials within 60 days prior to the study or concurrent with the study Known insulin dependent diabetes mellitus Unable to undergo either MRI or X-ray Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed Previous intra-articular steroid injection within the last 1 month Prisoners Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely surrounding the lesion - based on MRI/X-ray/arthroscopy Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Agili-C<br> | Device: Agili-C implant<br>* Agili-C implant<br>|
| Active Comparator: Surgical Standard of Care (SSOC)<br> | Procedure: SSOC<br>* microfracture and/or debridement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS Score | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Preoperative until 2 years postoperatively |