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

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

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 Overview

• Status: Completed
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: Open Reduction and Internal Fixation; Procedure: External Fixation; Procedure: Percutaneous Pinning; Procedure: Closed Reduction and casting

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W7
      • Fraser Health Authority
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • University of Manitoba
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • University of Western Ontario
• Singapore
  • Singapore, Singapore
    • National University of Singapore
• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Norton Healthcare
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 20114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Paul, Minnesota, United States, 55101
      • HealthPartners Institute for Education and Research
  • New York
    • Great Neck, New York, United States, 11021
      • North Shore - Long Island Jewish Health System
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Kettering Health Network
    • Cleveland, Ohio, United States, 44109
      • The MetroHealth System
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73126
      • University of Oklahoma
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internal Fixation; Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system	Procedure: Open Reduction and Internal Fixation; Internal fixation with a volar locking plating system
Experimental: External Fixation; External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.	Procedure: External Fixation; External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
Experimental: Pinning; Percutaneous pinning with any number of Kirschner wires	Procedure: Percutaneous Pinning; Pinning with any number of Kirschner wires
Active Comparator: No Surgery; Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint	Procedure: Closed Reduction and casting; Closed reduction and immobilization with a cast and/or splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan Hand Outcomes Questionnaire score	upper-extremity questionnaire	12months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rapid Assessment of Physical Activity score	questionnaire	pre-injury and 24months
SF-36 score	QOL questionnaire	12months
complications	Complication Checklist for Distal Radius Fracture	12months
Hand function	grip strength, lateral pinch strength, wrist motion	12months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Demographics	Participant age, income, education level, race/ethnicity	baseline
Comorbidities	Self-Administered Comorbidity Checklist	baseline
Therapy compliance	count of therapy sessions and description of therapy type	12months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Kevin C Chung, MD, MS, University of Michigan

Publications and helpful links

General Publications

• Chung KC, Song JW; WRIST Study Group. A guide to organizing a multicenter clinical trial. Plast Reconstr Surg. 2010 Aug;126(2):515-523. doi: 10.1097/PRS.0b013e3181df64fa.
• 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.
• Yoon AP, Wang Y, Wang L, Chung KC; and the WRIST Group. What Are the Tradeoffs in Outcomes after Casting Versus Surgery for Closed Extraarticular Distal Radius Fractures in Older Patients? A Statistical Learning Model. Clin Orthop Relat Res. 2021 Dec 1;479(12):2691-2700. doi: 10.1097/CORR.0000000000001865.
• Chung KC, Kim HM, Malay S, Shauver MJ; WRIST Group. Comparison of 24-Month Outcomes After Treatment for Distal Radius Fracture: The WRIST Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112710. doi: 10.1001/jamanetworkopen.2021.12710.
• Yoon AP, Wang C, Speth KA, Wang L, Chung KC; WRIST Group. Modifiable Factors Associated With Chronic Pain 1 Year After Operative Management of Distal Radius Fractures: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2028929. doi: 10.1001/jamanetworkopen.2020.28929.
• Hooper RC, Zhou N, Wang L, Shauver MJ, Chung KC; WRIST Group. Pre-injury activity predicts outcomes following distal radius fractures in patients age 60 and older. PLoS One. 2020 May 20;15(5):e0232684. doi: 10.1371/journal.pone.0232684. eCollection 2020.
• Chung KC, Cho HE, Kim Y, Kim HM, Shauver MJ; WRIST Group. Assessment of Anatomic Restoration of Distal Radius Fractures Among Older Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1919433. doi: 10.1001/jamanetworkopen.2019.19433.
• Chung KC, Malay S, Shauver MJ, Kim HM; WRIST Group. Assessment of Distal Radius Fracture Complications Among Adults 60 Years or Older: A Secondary Analysis of the WRIST Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e187053. doi: 10.1001/jamanetworkopen.2018.7053.
• Nasser JS, Huetteman HE, Shauver MJ, Chung KC. Older Patient Preferences for Internal Fixation after a Distal Radius Fracture: A Qualitative Study from the Wrist and Radius Injury Surgical Trial. Plast Reconstr Surg. 2018 Jul;142(1):34e-41e. doi: 10.1097/PRS.0000000000004454.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2012
• Primary Completion (Actual): February 3, 2018
• Study Completion (Actual): January 8, 2019

Study Registration Dates

• First Submitted: April 25, 2012
• First Submitted That Met QC Criteria: May 1, 2012
• First Posted (Estimate): May 2, 2012

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: elderly; Distal Radius Fracture; External Fixation; internal fixation; DRF; WRIST; VLPS; Multi center randomized trial
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: R01AR062066-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No