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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteochondritis Dissecans
• Intervention / Treatment: Device: DBX Putty; Procedure: Mosaicplasty

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Töölö Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DBX; DBX Putty in glass syringe	Device: DBX Putty; OCD of the knee will be treated with DBX Putty
Active Comparator: Mosaicplasty	Procedure: Mosaicplasty; Mosaicplasty procedure performed to treat OCD of the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Synthes GmbH
• Investigators: Principal Investigator: Jari Salo, MD, Töölö Hospital

Study record dates

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Estimate): June 26, 2012
• Last Update Submitted That Met QC Criteria: June 25, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: OCD; Osteochondritis Dissecans; Mosaicplasty; Demineralised Bone Matrix; DBX; DBX Putty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Cartilage Diseases; Osteochondritis; Osteochondritis Dissecans
• Other Study ID Numbers: STU-BIO-T-XX-001-01