NCT01589692

A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Distal Radius Fracture

Interventions

Type	Name	Description
PROCEDURE	Open Reduction and Internal Fixation	Internal fixation with a volar locking plating system
PROCEDURE	External Fixation	External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
PROCEDURE	Percutaneous Pinning	Pinning with any number of Kirschner wires
PROCEDURE	Closed Reduction and casting	Closed reduction and immobilization with a cast and/or splint

Timeline

• Start date: 2012-04-10
• Primary completion: 2018-02-03
• Completion: 2019-01-08
• First posted: 2012-05-02
• Last updated: 2019-02-11

Locations

24 sites across 3 countries: United States, Canada, Singapore