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| Sponsors and Collaborators: |
Université Catholique de Louvain Wright Medical Technology |
| Information provided by: | Université Catholique de Louvain |
| ClinicalTrials.gov Identifier: | NCT00274378 |
Purpose
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.
| Condition | Intervention | Phase |
|
Radius Fractures |
Device: ALLOMATRIX injectable putty in distal radius fractures |
Phase IV |
| MedlinePlus related topics: | Bone Grafts Fractures |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Allomatrix Injectable Putty in Distal Radius Fractures. Protocol for a Randomised, Controlled Clinical Study in Unstable Fractures of the Distal Radius |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | June 2008 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Olivier BARBIER, MD | 0032 2 7641111 ext 2523 | olivier.barbier@orto.ucl.ac.be |
| Contact: Orthopaedic resident, MD | 0032 2 7641111 ext 1617 |
| Belgium | |||||
| Cliniques Universitaires St-Luc | Recruiting | ||||
| Brussels, Belgium, 1200 | |||||
| Contact: Olivier BARBIER, MD 0032 2 7641111 ext 2523 olivier.barbier@orto.ucl.ac.be | |||||
| Principal Investigator: Olivier BARBIER, MD | |||||
| Université Catholique de Louvain |
| Wright Medical Technology |
| Principal Investigator: | Olivier BARBIER, MD | Cliniques Universitaires St-LUC, 1200 Brussels |
More Information
| Study ID Numbers: | Allomatrix radius UCL |
| First Received: | January 6, 2006 |
| Last Updated: | March 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00274378 |
| Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
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