Follow-Up Study Evaluating the Long Term Outcome of ChondroMimetic in the Treatment of Osteochondral Defects in the Knee

Study Overview
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Brief Summary
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To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of the knee.

Detailed Description
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This is an open-label, single center, extension study to the previous interventional study 0MCM0107 designed to investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in the treatment of osteochondral defects of the knee. Follow-up to 6-months was completed as part of study 0MCM0107. All 17 subjects who received ChondroMimetic in study 0MCM0107 are eligible for enrolment into this extension study regardless of their current follow-up period.

Official Title
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Follow-Up Study Evaluating the Long-Term Outcomes of ChondroMimetic in the Treatment of Osteochondral Defects (Extension Study of Protocol 0MCM0107)

Conditions
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Osteochondral Defect

Intervention / Treatment
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* Device: ChondroMimetic


Participation Criteria
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Eligibility Criteria
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Treated with a Chondromimetic device under Protocol 0MCM0107 and completed the required follow-up.
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chondromimetic<br>Treatment of osteochondral defect in the knee with Chondromimetic device(s) in previous study 0MCM0107 | Device: ChondroMimetic<br>* ChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from 0MCM0107 baseline in Modified Cincinnati Rating System | Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery. | 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up | 
| KOOS (Knee injury and Osteoarthritis Outcome Score | Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery. | Through study completion, an average of approximately 8 years follow-up | 
| Cartilage repair tissue quantity and quality using 3D quantitative MRI analysis | Morphological segmentation utilizing a programmed anatomical atlas for all bone and cartilage structures will be used to assess defect filling (using previous MRI scans from study 0MCM0107 as reference), and T2 mapping for cartilage repair tissue quality. | Through study completion, an average of approximately 8 years follow-up | 
| Osteochondral defect repair assessment | Defect repair outcomes will be assessed using the magnetic resonance observation of cartilage repair tissue (MOCART) subjective radiological scoring system. | Through study completion, an average of approximately 8 years follow-up | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Long-term safety will be assessed by physical and knee examination, and subject history since original treatment in study 0MCM0107 | 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up |