Follow-Up Study Evaluating the Long-Term Outcomes of ChondroMimetic in the Treatment of Osteochondral Defects (Extension Study of Protocol 0MCM0107)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteochondral Defect
- Sponsor
- Collagen Solutions
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
Long-term safety will be assessed by physical and knee examination, and subject history since original treatment in study 0MCM0107
Change from 0MCM0107 baseline in Modified Cincinnati Rating System
Time Frame: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery.
KOOS (Knee injury and Osteoarthritis Outcome Score
Time Frame: Through study completion, an average of approximately 8 years follow-up
Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery.
Cartilage repair tissue quantity and quality using 3D quantitative MRI analysis
Time Frame: Through study completion, an average of approximately 8 years follow-up
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.
Osteochondral defect repair assessment
Time Frame: Through study completion, an average of approximately 8 years follow-up
Defect repair outcomes will be assessed using the magnetic resonance observation of cartilage repair tissue (MOCART) subjective radiological scoring system.