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

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

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

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• National Institute on Aging (NIA)

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Kevin C Chung, MD, MS · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-10

Primary Completion

2018-02-03

Completion

2019-01-08

Countries

• United States
• Canada
• Singapore

Study Locations