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Completed

NCT Number: NCT03385642

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

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.

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Key information

Conditions

Osteochondral Defect

Sex eligibility

All sexes

Study type

Observational

Primary location

Uzsoki Hospital

Budapest, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Treated with a Chondromimetic device under Protocol 0MCM0107 and completed the required follow-up.

Treatment and study plan

ChondroMimetic

Device

ChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Collagen Solutions

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2017
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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