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

NCT ID: NCT03385642

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-29

Study Completion Date

2018-02-22

Brief Summary

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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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Detailed Description

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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.

Conditions

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Osteochondral Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chondromimetic

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

ChondroMimetic

Intervention Type DEVICE

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

Interventions

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ChondroMimetic

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Collagen Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laszlo Hangody, MD, PhD, DSc

Role: PRINCIPAL_INVESTIGATOR

Uzsoki Hospital

Locations

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Uzsoki Hospital

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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0MCM0107-2

Identifier Type: -

Identifier Source: org_study_id

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