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Allomatrix Injectable Putty in Distal Radius Fractures

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ClinicalTrials.gov Identifier: NCT00274378
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : July 30, 2009
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by:
Université Catholique de Louvain

Brief Summary:

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 or disease Intervention/treatment Phase
Radius Fractures Device: ALLOMATRIX injectable putty in distal radius fractures Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Hand ability: self-assesment questionnaire ABILHAND and DASH

Secondary Outcome Measures :
  1. Bone mineral density
  2. Radiological evaluation
  3. Hand impairment (strength, sensibilty, mobility)


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unstable distal radius fracture

Exclusion Criteria:

  • associated traumatic lesions
  • associated severe pathological conditions
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274378


Locations
Belgium
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain
Wright Medical Technology
Investigators
Principal Investigator: Olivier BARBIER, MD Cliniques Universitaires St-LUC, 1200 Brussels