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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2016-04-30

Brief Summary

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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

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Detailed Description

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Conditions

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Osteochondral Defects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Osteochondral lesions

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

Chondromimetic

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Osteochondral repair plug CM

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No