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NCT Number: NCT01589692

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

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fraser Health Authority, New Westminster, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Open Reduction and Internal Fixation

Procedure

Internal fixation with a volar locking plating system

External Fixation

Procedure

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

Percutaneous pinning

Procedure

Pinning with any number of Kirschner wires

Closed Reduction and casting

Procedure

Closed reduction and immobilization with a cast and/or splint

Primary outcomes

  1. Michigan Hand Outcomes Questionnaire score

    Time frame: 12months

    upper-extremity questionnaire

Secondary outcomes

  1. Change in Rapid Assessment of Physical Activity score

    Time frame: pre-injury and 24months

    questionnaire

  2. SF-36 score

    Time frame: 12months

    QOL questionnaire

  3. complications

    Time frame: 12months

    Complication Checklist for Distal Radius Fracture

  4. Hand function

    Time frame: 12months

    grip strength, lateral pinch strength, wrist motion

Other outcomes

  1. Participant Demographics

    Time frame: baseline

    Participant age, income, education level, race/ethnicity

  2. Comorbidities

    Time frame: baseline

    Self-Administered Comorbidity Checklist

  3. Therapy compliance

    Time frame: 12months

    count of therapy sessions and description of therapy type

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

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

Acronym: WRIST

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
May 2, 2012
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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