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

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Open Reduction and Internal Fixation
External Fixation
Percutaneous Pinning
Closed Reduction and casting
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring WRIST, Distal Radius Fracture, DRF, elderly, internal fixation, VLPS, External Fixation, Multi center randomized trial

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Connecticut
  • Norton Healthcare
  • Johns Hopkins University
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital
  • University of Michigan
  • Mayo Clinic
  • HealthPartners Institute for Education and Research
  • North Shore - Long Island Jewish Health System
  • University of Rochester
  • OrthoCarolina
  • Duke University
  • Wake Forest University
  • Kettering Health Network
  • The MetroHealth System
  • University of Oklahoma
  • University of Pennsylvania
  • University of Pittsburgh
  • University of Washington
  • Fraser Health Authority
  • University of Manitoba
  • University of Western Ontario
  • National University of Singapore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Internal Fixation

External Fixation

Pinning

No Surgery

Arm Description

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

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

Percutaneous pinning with any number of Kirschner wires

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

Outcomes

Primary Outcome Measures

Michigan Hand Outcomes Questionnaire score
upper-extremity questionnaire

Secondary Outcome Measures

Change in Rapid Assessment of Physical Activity score
questionnaire
SF-36 score
QOL questionnaire
complications
Complication Checklist for Distal Radius Fracture
Hand function
grip strength, lateral pinch strength, wrist motion

Full Information

First Posted
April 25, 2012
Last Updated
February 8, 2019
Sponsor
University of Michigan
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01589692
Brief Title
A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures
Acronym
WRIST
Official Title
A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures. The Wrist and Radius Injury Surgical Trial (WRIST)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2012 (Actual)
Primary Completion Date
February 3, 2018 (Actual)
Study Completion Date
January 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
WRIST, Distal Radius Fracture, DRF, elderly, internal fixation, VLPS, External Fixation, Multi center randomized trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internal Fixation
Arm Type
Experimental
Arm Description
Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system
Arm Title
External Fixation
Arm Type
Experimental
Arm Description
External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
Arm Title
Pinning
Arm Type
Experimental
Arm Description
Percutaneous pinning with any number of Kirschner wires
Arm Title
No Surgery
Arm Type
Active Comparator
Arm Description
Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint
Intervention Type
Procedure
Intervention Name(s)
Open Reduction and Internal Fixation
Intervention Description
Internal fixation with a volar locking plating system
Intervention Type
Procedure
Intervention Name(s)
External Fixation
Intervention Description
External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Pinning
Intervention Description
Pinning with any number of Kirschner wires
Intervention Type
Procedure
Intervention Name(s)
Closed Reduction and casting
Intervention Description
Closed reduction and immobilization with a cast and/or splint
Primary Outcome Measure Information:
Title
Michigan Hand Outcomes Questionnaire score
Description
upper-extremity questionnaire
Time Frame
12months
Secondary Outcome Measure Information:
Title
Change in Rapid Assessment of Physical Activity score
Description
questionnaire
Time Frame
pre-injury and 24months
Title
SF-36 score
Description
QOL questionnaire
Time Frame
12months
Title
complications
Description
Complication Checklist for Distal Radius Fracture
Time Frame
12months
Title
Hand function
Description
grip strength, lateral pinch strength, wrist motion
Time Frame
12months
Other Pre-specified Outcome Measures:
Title
Participant Demographics
Description
Participant age, income, education level, race/ethnicity
Time Frame
baseline
Title
Comorbidities
Description
Self-Administered Comorbidity Checklist
Time Frame
baseline
Title
Therapy compliance
Description
count of therapy sessions and description of therapy type
Time Frame
12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin C Chung, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
20114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
HealthPartners Institute for Education and Research
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
North Shore - Long Island Jewish Health System
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
OrthoCarolina
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Kettering Health Network
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
The MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73126
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fraser Health Authority
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
National University of Singapore
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
20375760
Citation
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.
Results Reference
background
PubMed Identifier
23608306
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.
Results Reference
background
PubMed Identifier
34142664
Citation
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.
Results Reference
derived
PubMed Identifier
34137830
Citation
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.
Results Reference
derived
PubMed Identifier
33337492
Citation
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.
Results Reference
derived
PubMed Identifier
32433648
Citation
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.
Results Reference
derived
PubMed Identifier
31951273
Citation
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.
Results Reference
derived
PubMed Identifier
30657531
Citation
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.
Results Reference
derived
PubMed Identifier
29952895
Citation
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.
Results Reference
derived

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

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