CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 target
Drug / intervention
ALLOMATRIX injectable putty in distal radius fracturesdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00274378
NCT00274378Phase 4Completed

Allomatrix Injectable Putty in Distal Radius Fractures. Protocol for a Randomised, Controlled Clinical Study in Unstable Fractures of the Distal Radius

Université Catholique de Louvain·interventional·Posted Jan 10, 2006·Updated Jul 30, 2009

In Brief

A Phase 4 clinical trial evaluating ALLOMATRIX injectable putty in distal radius fractures for Radius Fractures. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2006
Enrollment StartJun 1, 2005
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 20.5 years ago

Interventions

ALLOMATRIX injectable putty in distal radius fracturesdevice