Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects

Study Overview
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Brief Summary
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Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a historical control arm (microfracture) in the treatment of cartilage defects in the knee.

Official Title
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A Prospective, Open-Label, Multicenter Pivotal Study to Evaluate the Safety and Efficacy of GelrinC® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle: A Comparison to Historical Control Microfracture

Conditions
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Articular Cartilage Defects in the Knee Joint

Intervention / Treatment
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* Device: GelrinC
* Other: Microfracture historical control arm


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Age between 18 and 50. Single contained symptomatic lesion located on the femoral condyle of the femur graded as ICRS III or IV with less than 5 mm of bone loss below the subchondral plate. Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in diameter. BMI ≤35 Contralateral knee is asymptomatic, stable, fully functional and not medically treated. Main Exclusion Criteria: Presence of an additional grade III or IV symptomatic lesion. Recent Osteochondritis Dissecans within 1 year of baseline visit. Untreated ACL and/or PCL deficiency or Complex ligamentous instability of the knee. Patient is excluded if presenting untreated current meniscal tear or if previous menisci resection was within the last 6 months. Previous tendon repair or ligament reconstruction within the last 6 months. Failed Mosaicplasty or ACI or MACI or any other cartilage repair product. Microfracture performed less than 1 year before baseline visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GelrinC prospective treatment arm<br>Patients will undergo GelrinC implantation. | Device: GelrinC<br>* Patients will undergo GelrinC implantation.<br>|
| Other: Microfracture historical control arm<br>Microfracture historical control arm | Other: Microfracture historical control arm<br>* Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS). |  | 24 months post-surgery | 
| The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS). |  | 24 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cartilage damage, cartilage defect, chondral lesion, osteochondral lesion, femur, condyle