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



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:60 - Any
Updated:2/13/2019
Start Date:April 10, 2012
End Date:January 8, 2019

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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 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.


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)
We found this trial at
21
sites
Rochester, Minnesota 55905
Principal Investigator: David G Dennison, MD
Phone: 507-284-3916
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Dawn Laporte, MD
Phone: 410-502-2160
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Fraser J Leversedge, MD
Phone: 919-613-5747
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Robert Goitz, MD
Phone: 412-605-3245
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Warren Hammert, MD, DDS
Phone: 585-341-9304
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Seattle, Washington 98104
(206) 543-2100
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Kevin C Chung, MD, MS
Phone: 734-232-6171
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Centerville, Ohio 45459
Principal Investigator: Brent Bamberger, DO
Phone: 937-395-8483
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Charlotte, North Carolina 28207
Principal Investigator: Glenn Gaston, MD
Phone: 704-323-3176
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Cleveland, Ohio 44109
Phone: 216-778-8445
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Farmington, Connecticut 06030
Principal Investigator: Jennifer Wolf, MD
Phone: 860-679-4736
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Louisville, Kentucky 40207
Principal Investigator: Ethan Blackburn, MD
Phone: 502-333-2610
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New Westminster, British Columbia
Principal Investigator: Betrand Perey, MD
Phone: 604) 520-4855
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Thomas P Lehman, MD, PT
Phone: 405-271-8001
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Davis J Bozentka, MD
Phone: 215-615-0760
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Winston-Salem, North Carolina 27157
Principal Investigator: Zhingyu Li, MD, PhD
Phone: 336-716-9877
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