A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects

Terminated

• Conditions: Osteochondral Defects
• Interventions: Device: Chondromimetic

• Registration Number: NCT01209390
• Lead Sponsor: TiGenix n.v.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-06
• Study Start: 2010-09
• Study First Submitted QC: 2010-09-24
• Study First Posted: 2010-09-27
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-19
• Last Update Posted: 2011-09-20
• Primary Completion: 2015-09
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Signed patient informed consent
2. Shallow osteochondral defect ≤ 12 mm diameter and ≤ 8 mm depth in weight bearing area
3. Agree to actively participate in a rehabilitation protocol

Exclusion Criteria

1. Severe vascular or neurological disease
2. Uncontrolled diabetes
3. Severe degenerative joint disease
4. Pregnancy
5. Presence of infection at the site or in the joint space (e.g. osteomyelitis)
6. Diagnosis rheumatoidism
7. Advanced osteoarthritis as judged by the surgeon
8. Drug and/or alcohol abuse
9. Hypercalcemia
10. Known allergy to any of the components of the device (e.g. bovine collagen)
11. Bleeding disorders of any etiology
12. Steroidal or immunosuppressive maintenance therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osteochondral lesions	Chondromimetic	Patients with osteochondral lesions in the knee, the ankle, or other joint

Primary Outcome Measures

Name	Time	Method
Safety data	on ongoing basis up to 3 years	Safety data as measured by adverse device reactions

Secondary Outcome Measures

Name	Time	Method
EuroQoL-5D	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	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	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.

Trial Locations

Locations (4)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Uzsoki Hospital; 🇭🇺 Budapest, Hungary

Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom