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Allomatrix Injectable Putty in Distal Radius Fractures

NCT00274378 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-07-30

No results posted yet for this study

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.

Conditions

  • Radius Fractures

Interventions

DEVICE

ALLOMATRIX injectable putty in distal radius fractures

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    collaborator INDUSTRY

  • Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Olivier BARBIER, MD · Cliniques Universitaires St-LUC, 1200 Brussels

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00274378 on ClinicalTrials.gov