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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01589692
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dr. Kevin C. Chung, University of Michigan

Study Description
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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.


Condition or disease Intervention/treatment Phase
Distal Radius Fracture Procedure: Open Reduction and Internal Fixation Procedure: External Fixation Procedure: Percutaneous Pinning Procedure: Closed Reduction and casting Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures. The Wrist and Radius Injury Surgical Trial (WRIST)
Actual Study Start Date : April 10, 2012
Actual Primary Completion Date : February 3, 2018
Actual Study Completion Date : January 8, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Internal Fixation
Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system
 Procedure: Open Reduction and Internal Fixation
Internal fixation with a volar locking plating system
Experimental: External Fixation
External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
 Procedure: External Fixation
External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
Experimental: Pinning
Percutaneous pinning with any number of Kirschner wires
 Procedure: Percutaneous Pinning
Pinning with any number of Kirschner wires
Active Comparator: No Surgery
Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint
 Procedure: Closed Reduction and casting
Closed reduction and immobilization with a cast and/or splint


Outcome Measures
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Primary Outcome Measures :
  1. Michigan Hand Outcomes Questionnaire score [ Time Frame: 12months ]
    upper-extremity questionnaire


Secondary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589692


Locations
Show Show 24 study locations
Sponsors and Collaborators
University of Michigan
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Kevin C Chung, MD, MS University of Michigan
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Kevin C. Chung, Charles B. G. de Nancrede Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT01589692    
Other Study ID Numbers: R01AR062066-01A1 ( U.S. NIH Grant/Contract )
R01AR062066-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Kevin C. Chung, University of Michigan:
WRIST
Distal Radius Fracture
DRF
elderly
 internal fixation
VLPS
External Fixation
Multi center randomized trial
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries