A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects (OMCM)
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|ClinicalTrials.gov Identifier: NCT01209390|
Recruitment Status : Terminated (Slow recruitment rate)
First Posted : September 27, 2010
Last Update Posted : September 20, 2011
The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period.
The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting.
The secondary objectives are:
- Clinical outcome as assessed by patient reported EuroQoL-5D
- Structural repair as assessed by MRI
- The number of treatment failures and the time to treatment failure
- The ease of use of ChondroMimetic as reported by the surgeon
|Condition or disease||Intervention/treatment|
|Osteochondral Defects||Device: Chondromimetic|
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Official Title:||A Prospective, Open Label, Multi-centre, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||April 2016|
Patients with osteochondral lesions in the knee, the ankle, or other joint
The Chondromimetic implant is intended to serve as a scaffold for cellular and tissue ingrowth in osteochrondral defect repair such as bone and/or cartilage.
The plug consists of a chondral layer with collagen and GAG and an osseus layer with collagen, GAG, and calcium phosphate.
- Safety data [ Time Frame: on ongoing basis up to 3 years ]Safety data as measured by adverse device reactions
- EuroQoL-5D [ Time Frame: baseline, 6, 12, 24, 36 months ]The EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension
- MRI [ Time Frame: baseline, 12, 24, 36 months ]Structural repair will be assessed by MRI. The available MRIs will be collected and scored by an independent radiologist, using the published MOCART score , and one additional item, level of the subchondral bone plate.
- Failure rate [ Time Frame: 3 years ]Treatment failure is defined as "a re-intervention on the index lesion, prompted by persistence or recurrence of symptoms related to the index knee". The date of failure is the actual date of re-intervention.
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): NCT01209390
|University Hospitals Leuven|
|Leuven, Belgium, 3001|
|Freiburg, Germany, 79106|
|Budapest, Hungary, 1145|
|Cambridge, United Kingdom, CB2 0QQ|
|Principal Investigator:||Laszlo Hangody, MD||Uzsoki Hospital, Budapest, Hungary|