Use of Demineralised Bone Matrix (DBX) in Osteochondritis Dissecans (OCD)
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.
Device: DBX Putty
|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|
- 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
- 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.
DBX Putty in glass syringe
Device: DBX Putty
OCD of the knee will be treated with DBX Putty
|Active Comparator: Mosaicplasty||
Mosaicplasty procedure performed to treat OCD of the knee
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283737
|Principal Investigator:||Jari Salo, MD||Töölö Hospital|