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

Completed

• Conditions: Osteochondral Defect
• Interventions: Device: ChondroMimetic

• Registration Number: NCT03385642
• Lead Sponsor: Collagen Solutions

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.

Study Timeline

• Study Start: 2017-05-29
• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Primary Completion: 2018-02-22
• Study Completion: 2018-02-22
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-13
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chondromimetic	ChondroMimetic	Treatment of osteochondral defect in the knee with Chondromimetic device(s) in previous study 0MCM0107

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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	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	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	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	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.

Trial Locations

Locations (1)

Uzsoki Hospital; 🇭🇺 Budapest, Hungary