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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
304
Internal fixation with a volar locking plating system
External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
Pinning with any number of Kirschner wires
Closed reduction and immobilization with a cast and/or splint
University of Connecticut
Farmington, Connecticut, United States
Norton Healthcare
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
HealthPartners Institute for Education and Research
Saint Paul, Minnesota, United States
North Shore - Long Island Jewish Health System
Great Neck, New York, United States
...and 14 more locations
Michigan Hand Outcomes Questionnaire score
upper-extremity questionnaire
Time frame: 12months
Change in Rapid Assessment of Physical Activity score
questionnaire
Time frame: pre-injury and 24months
SF-36 score
QOL questionnaire
Time frame: 12months
complications
Complication Checklist for Distal Radius Fracture
Time frame: 12months
Hand function
grip strength, lateral pinch strength, wrist motion
Time frame: 12months
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