A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures
- Conditions
- Distal Radius Fracture
- Interventions
- Procedure: Percutaneous PinningProcedure: Open Reduction and Internal FixationProcedure: External FixationProcedure: Closed Reduction and casting
- Registration Number
- NCT01589692
- Lead Sponsor
- University of Michigan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
-
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pinning Percutaneous Pinning Percutaneous pinning with any number of Kirschner wires Internal Fixation Open Reduction and Internal Fixation Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system External Fixation External Fixation External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning. No Surgery Closed Reduction and casting Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint
- Primary Outcome Measures
Name Time Method Michigan Hand Outcomes Questionnaire score 12months upper-extremity questionnaire
- Secondary Outcome Measures
Name Time Method Change in Rapid Assessment of Physical Activity score pre-injury and 24months questionnaire
Hand function 12months grip strength, lateral pinch strength, wrist motion
SF-36 score 12months QOL questionnaire
complications 12months Complication Checklist for Distal Radius Fracture
Trial Locations
- Locations (24)
Duke University
🇺🇸Durham, North Carolina, United States
National University of Singapore
🇸🇬Singapore, Singapore
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Washington
🇺🇸Seattle, Washington, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
University of Connecticut
🇺🇸Farmington, Connecticut, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Rochester
🇺🇸Rochester, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
OrthoCarolina
🇺🇸Charlotte, North Carolina, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
North Shore - Long Island Jewish Health System
🇺🇸Great Neck, New York, United States
The MetroHealth System
🇺🇸Cleveland, Ohio, United States
Fraser Health Authority
🇨🇦New Westminster, British Columbia, Canada
Kettering Health Network
🇺🇸Centerville, Ohio, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Western Ontario
🇨🇦London, Ontario, Canada
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
HealthPartners Institute for Education and Research
🇺🇸Saint Paul, Minnesota, United States
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States