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

Phase 4

Withdrawn

• Conditions: Osteochondritis Dissecans
• Interventions: Device: DBX Putty; Procedure: Mosaicplasty

• Registration Number: NCT01283737
• Lead Sponsor: Synthes GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DBX	DBX Putty	DBX Putty in glass syringe
Mosaicplasty	Mosaicplasty	-

Primary Outcome Measures

Name	Time	Method
Change of Brittberg-Peterson functional assessment score from baseline until 12 months post-op	At enrollment (day -7), at full weight-bearing (6-8 weeks post-operative), 6 months post-operative, 12 months post-operative	Score 0-130 (see Clin Orthop Relat Res 2000 May;374:212-34) to assess function and pain

Secondary Outcome Measures

Name	Time	Method
Number of patients with complications to assess the safety of the use of the treatment	Enrolment (day -7) until 12 months post-operative	All adverse events and complications will be recorded throughout the trial and assessed for severity and causality.
Type and quality of the formed cartilage to assess the effectiveness of the treatment	12 months post-operative	The type and quality of the newly formed cartilage will be assessed with arthroscopy and/or MRI /dGEMRIC)

Trial Locations

Locations (1)

Töölö Hospital; 🇫🇮 Helsinki, Finland