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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 1, 2014
Last verified: May 2014
  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 21-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: 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: 623
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
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 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
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

Locations
United States, Connecticut
University of Connecticut Recruiting
Farmington, Connecticut, United States, 06030
Contact: Katy Coyle, RN    860-679-4736    kcoyle@uchc.edu   
Principal Investigator: Jennifer Wolf, MD         
Sub-Investigator: Craig Rodner, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lindsay Herder, BA    617-667-9921    lherder@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: Waldo E Floyd, BA    617-525-8635    wfloyd@partners.org   
Principal Investigator: Phillip Blazar, MD         
Sub-Investigator: Brandon Earp, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 20114
Contact: Rajesh Reddy, BA    617-643-1265    rkreddy@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: Melissa Shauver, MPH    734-232-6171    mshauver@umich.edu   
Contact: Sunitha Malay, MPH    734-763-1834    smalay@umich.edu   
Principal Investigator: Kevin C Chung, MD, MS         
Sub-Investigator: Steven Haase, MD         
Sub-Investigator: Jeff Lawton, MD         
Sub-Investigator: Kagen Ozer, MD         
Sub-Investigator: Jennifer Waljee, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tyson Scarbeck    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: Brian Hill, MD    651-254-2955    brian.w.hill@healthpartners.com   
Principal Investigator: Loree Kalliainen, MD         
Sub-Investigator: Christina Ward, MD         
Sub-Investigator: James Fletcher, MD         
Sub-Investigator: Cherrie Heinrich, MD         
Sub-Investigator: Katherine S Pico, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Allison McIntyre, MPH    585-341-9304    allisonw_mcintyre@urmc.rochester.edu   
Contact: Allison McIntyre, MPH         
Principal Investigator: Warren Hammert, MD, DDS         
United States, North Carolina
OrthoCarolina Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Ben Connell, BA    704-323-2268    ben.connell@orthocarolina.com   
Principal Investigator: Glenn Gaston, MD         
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Cameron Howe, CRC 1    919-613-5747    Cameron.howe@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: Debra Bullard    336-716-9877    dbullard@wakehealth.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: Brandi Palmer, MS, CCRP    937-395-8227    brandi.palmer@khnetwork.org   
Principal Investigator: Brent Bamberger, DO         
Sub-Investigator: Tim Harman, DO         
Principal Investigator: Adam Dann, DO         
Sub-Investigator: Mark Klug, MD         
MetroHealth System Not yet recruiting
Cleveland, Ohio, United States, 44109
Contact: Kevin Malone, MD    216-778-8825    kmalone@metrohealth.org   
Principal Investigator: Harry Hoyen, MD         
Sub-Investigator: Todd Bafus, MD         
Sub-Investigator: Kevin Malone, MD         
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73126
Contact: Kathy Carl, BS    405-271-8001    kathy-carl@ouhsc.edu   
Principal Investigator: Thomas Lehman, MD, PT         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Denise Knox, BS    215-615-0760    denise.e.knox@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: David Boman, BA    206-790-5118    dboman@uw.edu   
Principal Investigator: Jeffrey Friedrich, MD         
Sub-Investigator: Christopher H Allen, MD         
Sub-Investigator: Douglas Hanal, MD         
Sub-Investigator: Jerry Huang, MD         
Sub-Investigator: Jason Ko, MD         
Sub-Investigator: Nicholas Vedder, MD         
Canada, British Columbia
Fraser Health Authority Not yet recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Contact: Mauri Zomar    604) 520-4855    mauri.zomar@fraserhealth.ca   
Principal Investigator: Betrand Perey, MD         
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada
Contact: Alexandra Legary       alegary@panamclinic.com   
Principal Investigator: Tod Clark, MD         
Canada, Ontario
University of Western Ontario Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Kate Kelly, MSc, MPH    519-646-6100 ext 64640    kate.kelly@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
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: May 1, 2014
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 August 21, 2014