Allomatrix Injectable Putty in Distal Radius Fractures
Allomatrix is a combination of Demineralized Bone Matrix with a binding medium of calcium sulfate hemihydrate and carboxymethylcellulose. Allomatrix combines the osteoinductive capacity of DBM with the osteoconduction and controlled resorption of surgical grade calcium sulfate.
Unstable fractures of the distal radius do not resist displacement once it has been manipulated into an anatomical position.
There is a parallel between the quality of the anatomic result and the residual capacity of the wrist, except in older, low demanding patients.
Injectable osteoconductive cements have been introduced to fill voids in metaphyseal bone and may provide a better stability around hardware in osteoporotic bone and help maintain reduction of fracture fragments.Moreover, a product like ALLOMATRIX could accelerate and improve bone healing and fracture stability by its osteoinductive properties. However, the clinical significance of these new bone graft materials still have to be proven in a randomised controlled study set-up.
Device: ALLOMATRIX injectable putty in distal radius fractures
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Allomatrix Injectable Putty in Distal Radius Fractures. Protocol for a Randomised, Controlled Clinical Study in Unstable Fractures of the Distal Radius|
- Hand ability: self-assesment questionnaire ABILHAND and DASH
- Bone mineral density
- Radiological evaluation
- Hand impairment (strength, sensibilty, mobility)
|Study Start Date:||June 2005|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274378
|Cliniques Universitaires St-Luc|
|Brussels, Belgium, 1200|
|Principal Investigator:||Olivier BARBIER, MD||Cliniques Universitaires St-LUC, 1200 Brussels|