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

Description

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 18-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 Start Date

April 2012

Estimated Completion Date

April 2019

Interventions

  • Procedure: Open Reduction and Internal Fixation
  • Procedure: Percutaneous Pinning
  • Procedure: External Fixation
  • Procedure: Closed Reduction and casting

Specialties

  • Surgery: Surgical Technique
  • Emergency Medicine: Orthopedics/Sports Med
  • Orthopedics: Hand and Wrist,Shoulder and Elbow,Surgical Technique,Trauma
  • Physical Medicine & Rehab:

MeSH Terms

  • Bone
  • Distal Radius Fracture
  • External Fixation
  • Fractures
  • Percutaneous Pinning
  • Radius Fractures

Study ID

University of Michigan -- R01AR062066-01A1

Status

Unknown

Trial ID

NCT01589692

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

623

Sponsor

University of Michigan

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)

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (31)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
University of Connecticut - Farmington, Connecticut 100.1 miles None None None
North Shore Long Island Jewish Health System - Great Neck, New York 174.4 miles None None None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Kara Napolitano MPH 215-615-0760 kara.napolitano@uphs.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
University of Rochester - Rochester, New York 335.8 miles None None None
Johns Hopkins University - Baltimore, Maryland 356.6 miles Vaishali Laljani 410-502-2160 vparikh2@jhmi.edu
Johns Hopkins University - Baltimore, Maryland 356.6 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 407.0 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 407.0 miles None None None
University of Pittsburgh - Pittsburgh, Pennsylvania 478.5 miles John Fowler MD 412-605-3245 fowlerjr@upmc.edu
University of Pittsburgh - Pittsburgh, Pennsylvania 478.5 miles None None None
The MetroHealth System - Cleveland, Ohio 549.6 miles None None None
Duke University - Durham, North Carolina 609.0 miles Cameron Howe CRC 1 919-613-5747 Cameron.howe@duke.edu
Duke University - Durham, North Carolina 609.0 miles None None None
University of Michigan - Ann Arbor, Michigan 645.2 miles Melissa Shauver MPH 734-232-6171 mshauver@umich.edu
University of Michigan - Ann Arbor, Michigan 645.2 miles None None None
Wake Forest University - Winston-Salem, North Carolina 659.2 miles None None None
Wake Forest University - Winston-Salem, North Carolina 659.2 miles Debra Bullard 336-716-9877 dbullard@wakehealth.edu
Kettering Health Network - Centerville, Ohio 707.8 miles None None None
OrthoCarolina - Charlotte, North Carolina 721.9 miles None None None
Norton Healthcare - Louisville, Kentucky 813.5 miles Barbara Patterson BSN CCRC 502-333-2610 barbara.patterson@nortonhealthcare.org
Norton Healthcare - Louisville, Kentucky 813.5 miles None None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles None None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Debra Skifter 507-284-3916 skifter.debra@mayo.edu
HealthPartners Institute for Education and Research - St. Paul, Minnesota 1,112.4 miles None None None
University of Oklahoma - Oklahoma City, Oklahoma 1,493.5 miles None None None
University of Oklahoma - Oklahoma City, Oklahoma 1,493.5 miles Kathy Carl BA CCRP 405-271-8001 kathy-carl@ouhsc.edu
University of Washington - Seattle, Washington 2,489.6 miles None None None
University of Washington - Seattle, Washington 2,489.6 miles None None None

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