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Allomatrix Injectable Putty in Distal Radius Fractures

This study is currently recruiting participants.
Verified by Université Catholique de Louvain, March 2007

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   

U.S. FDA Resources

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

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
Estimated Study Completion Date:   June 2008

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • unstable distal radius fracture

Exclusion Criteria:

  • associated traumatic lesions
  • associated severe pathological conditions
  • pregnancy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274378

Contacts
Contact: Olivier BARBIER, MD     0032 2 7641111 ext 2523     olivier.barbier@orto.ucl.ac.be    
Contact: Orthopaedic resident, MD     0032 2 7641111 ext 1617    

Locations
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            

Sponsors and Collaborators
Université Catholique de Louvain
Wright Medical Technology

Investigators
Principal Investigator:     Olivier BARBIER, MD     Cliniques Universitaires St-LUC, 1200 Brussels    
  More Information


Publications:

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

Keywords provided by Université Catholique de Louvain:
radius fracture  
fracture fixation  
homologous bone transplantation  

Study placed in the following topic categories:
Fractures, Bone
Wounds and Injuries
Forearm Injuries
Disorders of Environmental Origin
Radius Fractures
Arm Injuries

ClinicalTrials.gov processed this record on December 03, 2008




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