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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01283737
Recruitment Status : Withdrawn
First Posted : January 26, 2011
Last Update Posted : June 26, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteochondritis Dissecans Device: DBX Putty Procedure: Mosaicplasty Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

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

Primary Outcome Measures :
  1. Change of Brittberg-Peterson functional assessment score from baseline until 12 months post-op [ Time Frame: 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 :
  1. Type and quality of the formed cartilage to assess the effectiveness of the treatment [ Time Frame: 12 months post-operative ]
    The type and quality of the newly formed cartilage will be assessed with arthroscopy and/or MRI /dGEMRIC)

  2. Number of patients with complications to assess the safety of the use of the treatment [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01283737

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Töölö Hospital
Helsinki, Finland
Sponsors and Collaborators
Synthes GmbH
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Principal Investigator: Jari Salo, MD Töölö Hospital

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Responsible Party: Synthes GmbH Identifier: NCT01283737     History of Changes
Other Study ID Numbers: STU-BIO-T-XX-001-01
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012
Keywords provided by Synthes GmbH:
Osteochondritis Dissecans
Demineralised Bone Matrix
DBX Putty
Additional relevant MeSH terms:
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Osteochondritis Dissecans
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases