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.
Study Type
OBSERVATIONAL
Enrollment
15
ChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee
Uzsoki Hospital
Budapest, Hungary
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
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