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Allomatrix Injectable Putty in Distal Radius Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00274378
First Posted: January 10, 2006
Last Update Posted: July 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wright Medical Technology
Information provided by:
Université Catholique de Louvain
  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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Université Catholique de Louvain:

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

Secondary Outcome Measures:
  • Bone mineral density
  • Radiological evaluation
  • Hand impairment (strength, sensibilty, mobility)

Estimated Enrollment: 50
Study Start Date: June 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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