Use of Demineralised Bone Matrix (DBX) in Osteochondritis Dissecans (OCD)

NCT ID: NCT01283737

Last Updated: 2012-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL

Brief Summary

This is a 1:1 randomised pilot study in 30 patients in 1 site in Helsinki, Finland.

The investigators hypothesize that function, pain, type and quality of cartilage in adult patients with osteochondritis dissecans of the knee will be better in the DBX group compared to the mosaicplasty group.

Conditions

Osteochondritis Dissecans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DBX

DBX Putty in glass syringe

Group Type: EXPERIMENTAL

DBX Putty

Intervention Type: DEVICE

OCD of the knee will be treated with DBX Putty

Mosaicplasty

Group Type: ACTIVE_COMPARATOR

Mosaicplasty

Intervention Type: PROCEDURE

Mosaicplasty procedure performed to treat OCD of the knee

Interventions

DBX Putty

OCD of the knee will be treated with DBX Putty

Intervention Type: DEVICE

Mosaicplasty

Mosaicplasty procedure performed to treat OCD of the knee

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Males or females, age between 18 years and 65 years
• Females of childbearing potential must have a negative serum or urine pregnancy test at the time of inclusion
• Females of childbearing potential must be willing to use effective means of birth control for at least 1 year post surgery. Medically acceptable contraceptives include:

1. Surgical sterilisation

2. Approved hormonal contraceptives

3. Barriers methods combined with a spermicide

4. An intrauterine device

5. Abstinence alone is not considered an acceptable method of contraception

• Late stage Osteochondritis Dissecans (ICD-10 code M93.2) of the knee classified as stage III or IV (Anderson MRI classification)
• Mature skeleton
• Written informed consent prior to any study specific procedures (except the procedures necessary to determine eligibility)
• Ability and willingness to comply with all study specific procedures, including attending all follow-up visits up to 12 months postoperative and completing questionnaires in a local language

Exclusion Criteria

• More than 1 knee affected
• Patients who can be treated with conservative treatment alone, unless there is evidence of at least 6 months failed previous treatment
• Systemic disease including AIDS, HIV, Hepatitis or any other disease that would prevent normal organ and marrow function.
• Patients undergoing systemic cortisone treatment or immunosuppressive therapy (e.g. avascular necrosis)
• Patients undergoing active cancer therapy (chemotherapy, radiation treatment).
• History of alcohol abuse or illegal drug use.
• Participation in any other device or drug trial within 3 months prior to the inclusion in the study
• Presence of at least one contraindication for DBX® Putty

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jari Salo, MD

Role: PRINCIPAL_INVESTIGATOR

Töölö Hospital

Locations

Töölö Hospital

Helsinki, , Finland

Countries

Finland

Other Identifiers

STU-BIO-T-XX-001-01

Identifier Type: -

Identifier Source: org_study_id