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

Distal Radius Fracture Clinical Trial

— WRIST  

Official title:

A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures. The Wrist and Radius Injury Surgical Trial (WRIST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589692
• Other study ID #: R01AR062066-01A1
• Secondary ID: R01AR062066-01A1
• Status: Completed
• Phase: N/A
• Start date: April 10, 2012
• Est. completion date: January 8, 2019

Study information

• Verified date: February 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: January 8, 2019
• Est. primary completion date: February 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Open Reduction and Internal Fixation
Internal fixation with a volar locking plating system
• External Fixation
External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
• Percutaneous Pinning
Pinning with any number of Kirschner wires
• Closed Reduction and casting
Closed reduction and immobilization with a cast and/or splint

Locations

Country	Name	City	State
Canada	University of Western Ontario	London	Ontario
Canada	Fraser Health Authority	New Westminster	British Columbia
Canada	University of Manitoba	Winnipeg	Manitoba
Singapore	National University of Singapore	Singapore
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Kettering Health Network	Centerville	Ohio
United States	OrthoCarolina	Charlotte	North Carolina
United States	The MetroHealth System	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	University of Connecticut	Farmington	Connecticut
United States	North Shore - Long Island Jewish Health System	Great Neck	New York
United States	Norton Healthcare	Louisville	Kentucky
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	HealthPartners Institute for Education and Research	Saint Paul	Minnesota
United States	University of Washington	Seattle	Washington
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA)

Countries where clinical trial is conducted

United States,  Canada,  Singapore, 

References & Publications (2)

Chung KC, Song JW; WRIST Study Group. A guide to organizing a multicenter clinical trial. Plast Reconstr Surg. 2010 Aug;126(2):515-23. doi: 10.1097/PRS.0b013e3181df64fa. Review. — View Citation

Wrist and Radius Injury Surgical Trial (WRIST) Study Group. Reflections 1 year into the 21-Center National Institutes of Health--funded WRIST study: a primer on conducting a multicenter clinical trial. J Hand Surg Am. 2013 Jun;38(6):1194-201. doi: 10.1016/j.jhsa.2013.02.027. Epub 2013 Apr 20. Erratum in: J Hand Surg Am. 2013 Aug;38(8):1662. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant Demographics	Participant age, income, education level, race/ethnicity	baseline
Other	Comorbidities	Self-Administered Comorbidity Checklist	baseline
Other	Therapy compliance	count of therapy sessions and description of therapy type	12months
Primary	Michigan Hand Outcomes Questionnaire score	upper-extremity questionnaire	12months
Secondary	Change in Rapid Assessment of Physical Activity score	questionnaire	pre-injury and 24months
Secondary	SF-36 score	QOL questionnaire	12months
Secondary	complications	Complication Checklist for Distal Radius Fracture	12months
Secondary	Hand function	grip strength, lateral pinch strength, wrist motion	12months