CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 304 enrolled
Drug / intervention
Open Reduction and Internal Fixation +3 moreprocedure
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/NCT01589692
NCT01589692N/ACompleted

A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures. The Wrist and Radius Injury Surgical Trial (WRIST)

University of Michigan·interventional·Posted May 2, 2012·Updated Feb 11, 2019

In Brief

A clinical study evaluating Open Reduction and Internal Fixation, External Fixation, and 2 other interventions for Distal Radius Fracture. Completed, enrolled 304 participants across 24 sites in 3 countries.

Detailed Summary

In the United States, over 300,000 individuals over age 65 suffer from distal radius fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of experience treating DRFs, management of elderly DRFs is still controversial. Close reduction and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures, common in the elderly, often collapse and displace. The three currently applied surgical techniques are close reduction and percutaneous pinning, external fixation with or without percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence indicates that locking plate fixation can permit elderly patients to move their hands and wrists much sooner in order to return to self-care activities more quickly. Although these outcomes are promising, there is no randomized controlled clinical trial to demonstrate that the more invasive, and perhaps more costly, plating technique is superior to the other simpler approaches. The specific aim of this 24-center randomized controlled trial is to compare outcomes of these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim is to follow a cohort of elderly patients who choose not to have surgery to evaluate outcomes following treatment by close reduction and casting alone. This clinical trial is the most ambitious study in hand surgery by assembling most of the leading centers in North America to collect evidence-based data to guide future treatment of this prevalent injury in the growing elderly population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Singapore, United States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2, 2012
Enrollment StartApr 10, 2012
Primary CompletionFeb 3, 2018
Study CompletionJan 8, 2019
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 14.2 years ago

Interventions

Open Reduction and Internal Fixationprocedure

Internal fixation with a volar locking plating system

External Fixationprocedure

External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.

Percutaneous Pinningprocedure

Pinning with any number of Kirschner wires

Closed Reduction and castingprocedure

Closed reduction and immobilization with a cast and/or splint