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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01589692
Acronym
WRIST
Enrollment
304
Registered
2012-05-02
Start date
2012-04-10
Completion date
2019-01-08
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture

Keywords

WRIST, Distal Radius Fracture, DRF, elderly, internal fixation, VLPS, External Fixation, Multi center randomized trial

Brief 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.

Interventions

Internal fixation with a volar locking plating system

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

Pinning with any number of Kirschner wires

PROCEDUREClosed Reduction and casting

Closed reduction and immobilization with a cast and/or splint

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
National Institute on Aging (NIA)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who have an unstable DRF for which surgical fixation is indicated o AO type A2, A3, C1, C2 * At least one of the following radiographic criteria indicating fracture instability * Dorsal angulation of greater than 10° * Radial inclination angle of less than 15° * Radial shortening of greater than 3mm * Patients with the ability to read and understand English (to complete study questionnaires) * Community-dwelling patients * Patients 60 years of age or older

Exclusion criteria

* Patients who have suffered open DRFs * Patients with bilateral DRFs * Patients with associated upper extremity fractures or ligament injuries (including ulnar styloid fracture, TFCC and wrist ligament injuries) requiring repair at the time of DRF fixation * Multi-trauma patients * Patients with prior DRF on the same wrist * Patients with comorbid conditions prohibiting surgery * Patients with neurologic disorders that affect hand, wrist or arm sensation or movement * Patients who have a history of dementia, Alzheimer's Disease or other serious psychiatric disorders * Patients with current substance abuse * Patients who do not agree to be randomized * Patients who have DRFs that are not equally suited for each procedure (i.e. severely comminuted fractures)

Design outcomes

Primary

MeasureTime frameDescription
Michigan Hand Outcomes Questionnaire score12monthsupper-extremity questionnaire

Secondary

MeasureTime frameDescription
SF-36 score12monthsQOL questionnaire
Change in Rapid Assessment of Physical Activity scorepre-injury and 24monthsquestionnaire
complications12monthsComplication Checklist for Distal Radius Fracture
Hand function12monthsgrip strength, lateral pinch strength, wrist motion

Other

MeasureTime frameDescription
Therapy compliance12monthscount of therapy sessions and description of therapy type
ComorbiditiesbaselineSelf-Administered Comorbidity Checklist
Participant DemographicsbaselineParticipant age, income, education level, race/ethnicity

Countries

Canada, Singapore, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026