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

NCT01209390 | Terminated

• 1 other identifier: OMCM-2010-01
• Study Type: observational
• Target: 8
• Locations: 4 countries
• Sites: 4

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

Conditions

Osteochondral Defects

Keywords

osteochondral; regenerative; repair; cartilage lesion

Outcome Measures

Primary Outcomes (1)

• Safety data

  Safety data as measured by adverse device reactions

  on ongoing basis up to 3 years

Secondary Outcomes (3)

• EuroQoL-5D

  baseline, 6, 12, 24, 36 months

• MRI

  baseline, 12, 24, 36 months

• Failure rate

  3 years

Study Arms (1)

Osteochondral lesions

Patients with osteochondral lesions in the knee, the ankle, or other joint

Device: Chondromimetic

Interventions

Chondromimetic DEVICE

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.

Also known as: Osteochondral repair plug, CM

Osteochondral lesions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited in selected centres, primary or secondary care, first line or referral treatment.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• TiGenix n.v.: lead

Study Sites (4)

University Hospitals Leuven

Leuven, 3001, Belgium

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Uzsoki Hospital

Budapest, 1145, Hungary

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Study Officials

• Laszlo Hangody, MD

  Uzsoki Hospital, Budapest, Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: September 27, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: April 1, 2016
• Last Updated: September 20, 2011

Record last verified: 2011-09

Locations

GB (1); BE (1); DE (1); HU (1)