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

This study is currently recruiting participants.
Verified October 2012 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: October 8, 2012
Last verified: October 2012
History of Changes
  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:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in Michigan Hand Outcomes Questionnaire score [ Time Frame: 6weeks, 3months, 6months, 12months, 24months ] [ 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: 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 ]

Estimated Enrollment: 864
Study Start Date: April 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internal Fixation Procedure: Open Reduction and Internal Fixation
Internal fixation with a volar locking plating system
Experimental: External Fixation Procedure: External Fixation
External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
Experimental: Pinning Procedure: Percutaneous Pinning
Pinning with any number of Kirschner wires
Active Comparator: No Surgery 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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589692

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

Locations
United States, Connecticut
University of Connecticut Recruiting
Farmington, Connecticut, United States, 06030
Contact: Jennifer M Wolf, MD     860-679-4253     jmwolf@uchc.edu    
Contact: Robin Leger, RN, MS, PhD     860-679-4932     rleger@uchc.edu    
Principal Investigator: Jennifer Wolf, MD            
Sub-Investigator: Craig Rodner, MD            
United States, Illinois
Southern Illinois University Recruiting
Springfield, Illinois, United States, 62794
Contact: Michael Neumeister, MD     217-545-7018     mneumeister@siumed.edu    
Contact: Jenny Koechle, MPH     217-545-7014     jkoechle@siumed.edu    
Principal Investigator: Micahel Neumeister, MD            
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Tamara Rozental, MD     617-667-1273     trozenta@bidmc.harvard.edu    
Contact: Laura Deschamps, BA     617-667-9921     ldescham@bidmc.harvard.edu    
Principal Investigator: Tamara Rozental, MD            
Sub-Investigator: Paul Appleton, MD            
Sub-Investigator: Edward Rodriguez, MD            
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Phillip Blazar, MD     617-732-5384     pblazar@partners.org    
Contact: Dexter Louie     617-525-8635     dllouie@partners.org    
Principal Investigator: Phillip Blazar, MD            
Sub-Investigator: Brandon Earp, MD            
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 20114
Contact: David Ring, MD, PhD     617-643-7527     dring@partners.org    
Contact: Jillian Gruber, BA     617-643-1265     jsgruber@partners.org    
Principal Investigator: David Ring, MD, PhD            
Sub-Investigator: Jesse Jupiter, MD, MA            
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kevin C Chung, MD, MS     734-936-5885     kecchung@umich.edu    
Contact: Melissa J Shauver, MPH     734-232-6171     mshauver@umich.edu    
Principal Investigator: Kevin C Chung, MD, MS            
Sub-Investigator: Steven Haase, MD            
Sub-Investigator: Jeff Lawton, MD            
Sub-Investigator: Kagen Ozer, MD            
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: David Dennison, MD     507-284-2806     dennison.david@mayo.edu    
Contact: Tyson Scrabeck     507-538-1016     scrabeck.tyson@mayo.edu    
Principal Investigator: David Dennison, MD            
Sub-Investigator: Sanjeev Kakar, MD            
Sub-Investigator: Alexander Shin, MD            
HealthPartners Institute for Education and Research Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Loree Kalliainen, MD     651-254-4870     loree.k.kalliainen@healthpartners.org    
Contact: Brian Hill, MD     651-254-2955     brian.w.hill@healthpartners.com    
Principal Investigator: Loree Kalliainen, MD            
Sub-Investigator: Felicity Fishman, MD            
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Warren Hammert, MD, DDS     585-275-5117     warren_hammert@urmc.rochester.edu    
Contact: Allison McIntyre, MPH     585-341-9304     allisonw_mcintyre@urmc.rochester.edu    
Principal Investigator: Warren Hammert, MD, DDS            
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Fraser Leversedge, MD     919-613-4541     fraser.leversedge@duke.edu    
Contact: Suzanne Finley     919-684-3193     suzanne.finley@duke.edu    
Principal Investigator: Fraser Leversedge, MD            
Sub-Investigator: Marc Richards, MD            
Sub-Investigator: David Ruch, MD            
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Zhongyu Li, MD, PhD     336-716-9351     zli@wfubmc.edu    
Contact: Beth Smithq, PhD     336-716-6432     bpsmith@wfubmc.edu    
Principal Investigator: Zhingyu Li, MD, PhD            
Sub-Investigator: Andrew Koman, MD            
United States, Ohio
Kettering Health Network Recruiting
Centerville, Ohio, United States, 45459
Contact: Brent Bamberger, DO     937-428-0400 ext 244     bbamberger@oaswo.edu    
Contact: Carla Robinson     937-428-0400 ext 244     crobinson@oaswo.com    
Principal Investigator: Brent Bamberger, DO            
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73126
Contact: Thomas Lehman, MD, PT     405-271-4426     thomas-lehman@ouhsc.edu    
Contact: Kathy Carl, BA     (405) 271-8001 ext 47977     kathy-carl@ouhsc.edu    
Principal Investigator: Thomas Lehman, MD, PT            
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David Bozentka, MD     215-349-5773     david.bozentka@uphs.upenn.edu    
Principal Investigator: Davis Bozentka, MD            
Sub-Investigator: Scott Levin, MD            
Sub-Investigator: David Steinberg, MD            
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Jeffrey Friedrich, MD     206-744-3183     jfriedri@u.washington.edu    
Principal Investigator: Jeffrey Friedrich, MD            
Canada, Ontario
University of Western Ontario Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Ruby Grewal, MD, MS     519-646-6286     rgrewa@uwo.ca    
Contact: Kristie Millman     519-646-6100 ext 64875     kristie.millman@sjch.london.on.ca    
Principal Investigator: Rudy Grewal, MD, MS            
Singapore
National University of Singapore Recruiting
Singapore, Singapore
Contact: Sandeep Sebastin, MCh     65 67725549     sandeepsebastin@gmail.com    
Contact: Sally Tay     65 6772 6814     sally_pl_tay@nuhs.edu.sg    
Principal Investigator: Sandeep Sebastin, MCh            
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, R01AR062066-01A1
Study First Received: April 25, 2012
Last Updated: October 8, 2012
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
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on May 21, 2013