Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondromimetic | Treatment of osteochondral defect in the knee with Chondromimetic device(s) in previous study 0MCM0107 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChondroMimetic | Device | ChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee |
|
| 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 |
Not provided
Not provided
Treated with a Chondromimetic device under Protocol 0MCM0107 and completed the required follow-up.
Not provided
Not provided
Not provided
Not provided
All subjects were treated with a Chondromimetic device under Protocol 0MCM0107
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laszlo Hangody, MD, PhD, DSc | Uzsoki Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uzsoki Hospital | Budapest | Hungary |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided