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

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ClinicalTrials.gov Identifier: NCT03385642
Recruitment Status : Completed
First Posted : December 28, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteochondral Defect Device: ChondroMimetic

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.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-Up Study Evaluating the Long-Term Outcomes of ChondroMimetic in the Treatment of Osteochondral Defects (Extension Study of Protocol 0MCM0107)
Actual Study Start Date : May 29, 2017
Actual Primary Completion Date : February 22, 2018
Actual Study Completion Date : February 22, 2018

Group/Cohort Intervention/treatment
Chondromimetic
Treatment of osteochondral defect in the knee with Chondromimetic device(s) in previous study 0MCM0107
Device: ChondroMimetic
ChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee




Primary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects were treated with a Chondromimetic device under Protocol 0MCM0107
Criteria
Treated with a Chondromimetic device under Protocol 0MCM0107 and completed the required follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385642


Locations
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Hungary
Uzsoki Hospital
Budapest, Hungary
Sponsors and Collaborators
Collagen Solutions
Investigators
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Principal Investigator: Laszlo Hangody, MD, PhD, DSc Uzsoki Hospital
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Responsible Party: Collagen Solutions
ClinicalTrials.gov Identifier: NCT03385642    
Other Study ID Numbers: 0MCM0107-2
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteochondrosis
Bone Diseases
Musculoskeletal Diseases