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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Synthes GmbH
ClinicalTrials.gov Identifier:
NCT01283737
First received: May 28, 2010
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Osteochondritis Dissecans
 Device: DBX Putty
Procedure: Mosaicplasty
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Synthes GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Score 0-130 (see Clin Orthop Relat Res 2000 May;374:212-34) to assess function and pain


Secondary Outcome Measures:
  • Type and quality of the formed cartilage to assess the effectiveness of the treatment [ Time Frame: 12 months post-operative ] [ Designated as safety issue: No ]
    The type and quality of the newly formed cartilage will be assessed with arthroscopy and/or MRI /dGEMRIC)

  • 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 ] [ Designated as safety issue: Yes ]
    All adverse events and complications will be recorded throughout the trial and assessed for severity and causality.


Enrollment: 0
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283737

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

No publications provided

Responsible Party: Synthes GmbH
ClinicalTrials.gov Identifier: NCT01283737     History of Changes
Other Study ID Numbers: STU-BIO-T-XX-001-01
Study First Received: May 28, 2010
Last Updated: June 25, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by Synthes GmbH:
Osteochondritis Dissecans
OCD
Mosaicplasty
 Demineralised Bone Matrix
DBX
DBX Putty

Additional relevant MeSH terms:
Osteochondritis
Osteochondritis Dissecans
Bone Diseases
 Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on June 18, 2013