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

Osteochondritis Dissecans Clinical Trial

Official title:

A Randomized, Subject-blind, Controlled Pilot Trial to Evaluate the Effectiveness and Safety of the Use of Demineralized Bone Matrix (DBX®) Versus Mosaicplasty in the Treatment of Late-Stage Osteochondritis Dissecans (OCD) of the Knee in Patients With a Mature Skeleton

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01283737
• Other study ID #: STU-BIO-T-XX-001-01
• Status: Withdrawn
• Phase: Phase 4
• First received: May 28, 2010
• Last updated: June 25, 2012

Study information

• Verified date: June 2012
• Source: Synthes GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteochondritis
• Osteochondritis Dissecans

Intervention

Device:
• DBX Putty
OCD of the knee will be treated with DBX Putty

Procedure:
• Mosaicplasty
Mosaicplasty procedure performed to treat OCD of the knee

Locations

Country	Name	City	State
Finland	Töölö Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Synthes GmbH

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Brittberg-Peterson functional assessment score from baseline until 12 months post-op	Score 0-130 (see Clin Orthop Relat Res 2000 May;374:212-34) to assess function and pain	At enrollment (day -7), at full weight-bearing (6-8 weeks post-operative), 6 months post-operative, 12 months post-operative	No
Secondary	Type and quality of the formed cartilage to assess the effectiveness of the treatment	The type and quality of the newly formed cartilage will be assessed with arthroscopy and/or MRI /dGEMRIC)	12 months post-operative	No
Secondary	Number of patients with complications to assess the safety of the use of the treatment	All adverse events and complications will be recorded throughout the trial and assessed for severity and causality.	Enrolment (day -7) until 12 months post-operative	Yes