A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures. The Wrist and Radius Injury Surgical Trial (WRIST)

Status: Completed
Location: See all (24) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: No
View:

• 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

Locations
United States
Connecticut
University of Connecticut
Farmington
Kentucky
Norton Healthcare
Louisville
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Maryland
Johns Hopkins University
Baltimore
Michigan
University of Michigan
Ann Arbor
Minnesota
Mayo Clinic
Rochester
HealthPartners Institute for Education and Research
Saint Paul
North Carolina
OrthoCarolina
Charlotte
Duke University
Durham
Wake Forest University
Winston-salem
New York
North Shore - Long Island Jewish Health System
Great Neck
University of Rochester
Rochester
Ohio
Kettering Health Network
Centerville
The MetroHealth System
Cleveland
Oklahoma
University of Oklahoma
Oklahoma City
Pennsylvania
University of Pennsylvania
Philadelphia
University of Pittsburgh
Pittsburgh
Washington
University of Washington
Seattle
Other Locations
Canada
University of Western Ontario
London
Fraser Health Authority
New Westminster
University of Manitoba
Winnipeg
Singapore
National University of Singapore
Singapore
Time Frame
Start Date: April 10, 2012
Completion Date: January 8, 2019
Participants
Target number of participants: 304
Treatments
Experimental: Internal Fixation
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.
Experimental: Pinning
Percutaneous 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
Authors
Blaine T Bafus, Brent Bamberger, Steven C Haase, Jennifer Wolf, David G Dennison, Yuri C Lansinger, Craig Rodner, Scott Levin, John Fowler, Lois K Osier, John S Gaul, David W Martineau, Katharine S Pico, Kyle Chepla, Bryan J Loeffler, Erik A Hasenboehler, Gavin D. O'Mahony, David P Steinberg, Robert Goitz, Cherrie A Heinrich, Fraser J Leversedge, Greg M Osgood, Christina M Ward, Sanjeev Kakar, David S Ruch, Bram Kaufman, Jennifer F Waljee, Timothy W Harman, Babar Shafiq, Roderick B Jordan, John R Lien, Ethan Blackburn, Thomas P Lehman, Harry A Hoyen, Warren Hammert, Benjamin R Graves, Daniel R Lewis, Dawn Laporte, Alexander Y Shin, Marco Rizzo, James W Fletcher, Kevin C Chung, Erica D Sears, Glenn Gaston, Nina Suh, Christopher Chadderdon, Tod Clark, Graham King, Paul C Perlick, Kagen Ozer, Betrand Perey, Davis J Bozentka, Ali Totonchil, Rudy Grewal, Zhingyu Li, Scott Lifchez, Marc J Richards, Ashish Y Mahjan, Alan Ward, Ken A Faber, Jaimie Shores, Andrew Koman
Sponsors
Collaborators: National Institute on Aging (NIA), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Leads: University of Michigan

This content was sourced from clinicaltrials.gov

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