A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects (OMCM)
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
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective, Open Label, Multi-centre, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects|
- Safety data [ Time Frame: on ongoing basis up to 3 years ] [ Designated as safety issue: Yes ]Safety data as measured by adverse device reactions
- EuroQoL-5D [ Time Frame: baseline, 6, 12, 24, 36 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|