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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Michigan
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Dr. Kevin C. Chung, University of Michigan
ClinicalTrials.gov Identifier:
NCT01589692
First received: April 25, 2012
Last updated: October 13, 2014
Last verified: October 2014

April 25, 2012
October 13, 2014
April 2012
October 2014   (final data collection date for primary outcome measure)
Change in Michigan Hand Outcomes Questionnaire score [ Time Frame: 12months ] [ Designated as safety issue: No ]
Change in Michigan Hand Outcomes Questionnaire score [ Time Frame: 6weeks, 3months, 6months, 12months, 24months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01589692 on ClinicalTrials.gov Archive Site
  • Participant Demographics [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Participant age, income, education level, race/ethnicity will be collected to explore possible associations between outcomes and demographic factors.
  • Comorbidity [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    Participant comorbidities will be collected to explore possible associations btwn comorbidities and outcomes
  • Change in Rapid Assessment of Physical Activity score [ Time Frame: 24months ] [ Designated as safety issue: No ]
  • Change in SF-36 score [ Time Frame: 12months ] [ Designated as safety issue: No ]
  • Bone Mineral Density Testing [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    participant bone mineral density will be collected to control for the possible confounding effect of low bone mineral density
  • complications [ Time Frame: 12months ] [ Designated as safety issue: Yes ]
    frequency and type of complications will be assess to determine if particular participant or procedure factors are associated with increased complication frequency
  • Therapy compliance [ Time Frame: 6weeks ] [ Designated as safety issue: No ]
    Therapy compliance will be assessed to control for the possible confounding factor of low therapy compliance.
  • Change in Hand function [ Time Frame: 12months ] [ Designated as safety issue: No ]
  • Participant Demographics [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Participant age, income, education level, race/ethnicity will be collected to explore possible associations between outcomes and demographic factors.
  • Comorbidity [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    Participant comorbidities will be collected to explore possible associations btwn comorbidities and outcomes
  • Change in Rapid Assessment of Physical Activity score [ Time Frame: baseline, 24months ] [ Designated as safety issue: No ]
  • Change in SF-36 score [ Time Frame: baseline, 2weeks, 6weeks, 3months, 6months, 12months, 24months ] [ Designated as safety issue: No ]
  • Bone Mineral Density Testing [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    participant bone mineral density will be collected to control for the possible confounding effect of low bone mineral density
  • complications [ Time Frame: 24months ] [ Designated as safety issue: Yes ]
    frequency and type of complications will be assess to determine if particular participant or procedure factors are associated with increased complication frequency
  • Therapy compliance [ Time Frame: 6weeks ] [ Designated as safety issue: No ]
    Therapy compliance will be assessed to control for the possible confounding factor of low therapy compliance.
  • Change in Hand function [ Time Frame: 6weeks, 3months, 6months, 12months, 24months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)

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 18-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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Distal Radius Fracture
  • 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
  • Experimental: Internal Fixation
    Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system
    Intervention: Procedure: Open Reduction and Internal Fixation
  • Experimental: External Fixation
    External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
    Intervention: Procedure: External Fixation
  • Experimental: Pinning
    Percutaneous pinning with any number of Kirschner wires
    Intervention: Procedure: Percutaneous Pinning
  • Active Comparator: No Surgery
    Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint
    Intervention: Procedure: Closed Reduction and casting

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
623
July 2016
October 2014   (final data collection date for primary outcome measure)

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 whose delay to emergency department or urgent care presentation was greater than 2 weeks
  • 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)
Both
60 Years and older
No
Contact: Kevin C Chung, MD, MS 734-936-5885 kecchung@umich.edu
United States,   Canada,   Singapore
 
NCT01589692
R01AR062066-01A1, R01AR062066-01A1
Yes
Dr. Kevin C. Chung, University of Michigan
University of Michigan
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Institute on Aging (NIA)
Principal Investigator: Kevin C Chung, MD, MS University of Michigan
University of Michigan
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP