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

NCT01589692 | Completed DMC

• 1 other identifier: R01AR062066-01A1
• Study Type: interventional
• Target: 304
• Locations: 3 countries
• Sites: 24

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.

Conditions

Distal Radius Fracture

Keywords

WRIST; Distal Radius Fracture; DRF; elderly; internal fixation; VLPS; External Fixation; Multi center randomized trial

Outcome Measures

Primary Outcomes (1)

• Michigan Hand Outcomes Questionnaire score

  upper-extremity questionnaire

  12months

Secondary Outcomes (4)

• Change in Rapid Assessment of Physical Activity score

  pre-injury and 24months

• SF-36 score

  12months

• complications

  12months

• Hand function

  12months

Other Outcomes (3)

• Participant Demographics

  baseline

• Comorbidities

  baseline

• Therapy compliance

  12months

Study Arms (4)

Internal Fixation

EXPERIMENTAL

Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system

Procedure: Open Reduction and Internal Fixation

External Fixation

EXPERIMENTAL

External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.

Procedure: External Fixation

Pinning

EXPERIMENTAL

Percutaneous pinning with any number of Kirschner wires

Procedure: Percutaneous Pinning

No Surgery

ACTIVE COMPARATOR

Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint

Procedure: Closed Reduction and casting

Interventions

Open Reduction and Internal Fixation PROCEDURE

Internal fixation with a volar locking plating system

Internal Fixation

External Fixation PROCEDURE

External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.

External Fixation

Percutaneous Pinning PROCEDURE

Pinning with any number of Kirschner wires

Pinning

Closed Reduction and casting PROCEDURE

Closed reduction and immobilization with a cast and/or splint

No Surgery

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (24)

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Norton Healthcare

Louisville, Kentucky, 40241, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 20114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

HealthPartners Institute for Education and Research

Saint Paul, Minnesota, 55101, United States

Location

North Shore - Long Island Jewish Health System

Great Neck, New York, 11021, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Kettering Health Network

Centerville, Ohio, 45459, United States

Location

The MetroHealth System

Cleveland, Ohio, 44109, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73126, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Fraser Health Authority

New Westminster, British Columbia, V3L 3W7, Canada

Location

University of Manitoba

Winnipeg, Manitoba, Canada

Location

University of Western Ontario

London, Ontario, N6A 4V2, Canada

Location

National University of Singapore

Singapore, Singapore

Location

Related Publications (10)

• 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.

  PMID: 20375760 BACKGROUND

• 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.

  PMID: 23608306 BACKGROUND

• Jayaram M, Wu H, Yoon AP, Kane RL, Wang L, Chung KC. Comparison of Distal Radius Fracture Outcomes in Older Adults Stratified by Chronologic vs Physiologic Age Managed With Casting vs Surgery. JAMA Netw Open. 2023 Feb 1;6(2):e2255786. doi: 10.1001/jamanetworkopen.2022.55786.

  PMID: 36780156 DERIVED

• 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.

  PMID: 34142664 DERIVED

• 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.

  PMID: 34137830 DERIVED

• 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.

  PMID: 33337492 DERIVED

• 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.

  PMID: 32433648 DERIVED

• 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.

  PMID: 31951273 DERIVED

• 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.

  PMID: 30657531 DERIVED

• 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.

  PMID: 29952895 DERIVED

MeSH Terms

Conditions

Wrist Fractures

Interventions

Open Fracture Reduction; Fracture Fixation, Internal; External Fixators

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Kevin C Chung, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Charles B. G. de Nancrede Professor of Surgery

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: May 2, 2012
• Study Start: April 10, 2012
• Primary Completion: February 3, 2018
• Study Completion: January 8, 2019
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

SG (1); US (20); CA (3)