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

Not Applicable

Completed

• Conditions: Distal Radius Fracture
• Interventions: Procedure: Percutaneous Pinning; Procedure: Open Reduction and Internal Fixation; Procedure: External Fixation; Procedure: 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-04-10
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Primary Completion: 2018-02-03
• Study Completion: 2019-01-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

Read More

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)

Read More

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