A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures
NCT ID: NCT01589692
Last Updated: 2019-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
304 participants
INTERVENTIONAL
2012-04-10
2019-01-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Internal Fixation
Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system
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.
External Fixation
External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
Pinning
Percutaneous pinning with any number of Kirschner wires
Percutaneous Pinning
Pinning with any number of Kirschner wires
No Surgery
Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint
Closed Reduction and casting
Closed reduction and immobilization with a cast and/or splint
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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 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)
60 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
National Institute on Aging (NIA)
NIH
University of Michigan
OTHER
Responsible Party
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Dr. Kevin C. Chung
Charles B. G. de Nancrede Professor of Surgery
Principal Investigators
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Kevin C Chung, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Connecticut
Farmington, Connecticut, United States
Norton Healthcare
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
HealthPartners Institute for Education and Research
Saint Paul, Minnesota, United States
North Shore - Long Island Jewish Health System
Great Neck, New York, United States
University of Rochester
Rochester, New York, United States
OrthoCarolina
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Kettering Health Network
Centerville, Ohio, United States
The MetroHealth System
Cleveland, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
Fraser Health Authority
New Westminster, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
University of Western Ontario
London, Ontario, Canada
National University of Singapore
Singapore, , Singapore
Countries
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References
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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.
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.
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.
Other Identifiers
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