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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of Michigan
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
ClinicalTrials.gov Identifier:
NCT01589692
First received: April 25, 2012
Last updated: February 4, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention Phase
Distal Radius Fracture
Procedure: Open Reduction and Internal Fixation
Procedure: External Fixation
Procedure: Percutaneous Pinning
Procedure: Closed Reduction and casting
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in Michigan Hand Outcomes Questionnaire score [ Time Frame: 12months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 623
Study Start Date: April 2012
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589692

Contacts
Contact: Kevin C Chung, MD, MS 734-936-5885 kecchung@umich.edu

  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
Principal Investigator: Kevin C Chung, MD, MS University of Michigan
  More Information

Publications:
Responsible Party: Dr. Kevin C. Chung, Charles B. G. de Nancrede Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT01589692     History of Changes
Other Study ID Numbers: R01AR062066-01A1 
Study First Received: April 25, 2012
Last Updated: February 4, 2016
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by University of Michigan:
WRIST
Distal Radius Fracture
DRF
elderly
internal fixation
VLPS
External Fixation
Multi center randomized trial

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Arm Injuries
Forearm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on February 08, 2016