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

Osteochondral Defects Clinical Trial

— OMCM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01209390
• Other study ID #: OMCM-2010-01
• Status: Terminated
• Phase: N/A
• First received: August 6, 2010
• Last updated: September 19, 2011
• Start date: September 2010
• Est. completion date: April 2016

Study information

• Verified date: September 2011
• Source: TiGenix n.v.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteochondral Defects

Intervention

Device:
• Chondromimetic
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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
Germany	Universitätsklinikum Freiburg	Freiburg
Hungary	Uzsoki Hospital	Budapest
United Kingdom	Addenbrookes Hospital	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
TiGenix n.v.

Countries where clinical trial is conducted

Belgium,  Germany,  Hungary,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety data	Safety data as measured by adverse device reactions	on ongoing basis up to 3 years	Yes
Secondary	EuroQoL-5D	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	baseline, 6, 12, 24, 36 months	No
Secondary	MRI	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.	baseline, 12, 24, 36 months	No
Secondary	Failure rate	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.	3 years	Yes