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

DePuy Synthes

Status and phase

Withdrawn

Phase 4

Conditions

Osteochondritis Dissecans

Treatments

Device: DBX Putty

Procedure: Mosaicplasty

Study type

Interventional

Funder types

Industry

Identifiers

NCT01283737

STU-BIO-T-XX-001-01

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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