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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:
Sponsor: Synthes GmbH

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • 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.


Original Secondary Outcome: Same as current

Information By: Synthes GmbH

Dates:
Date Received: May 28, 2010
Date Started:
Date Completion:
Last Updated: June 25, 2012
Last Verified: June 2012