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Distal Radius FractureWRISTNCT01589692

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

A study testing Open Reduction and Internal Fixation, External Fixation and Percutaneous Pinning in people with Distal Radius Fracture, run by University of Michigan at 24 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Distal Radius Fracture
What is being tested?
Open Reduction and Internal Fixation, External Fixation and Percutaneous Pinning
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
24 sitesin 3 countries
Study dates
10 Apr 2012to 8 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Patients with the ability to read and understand English (to complete study questionnaires)
  • Community-dwelling patients
  • Patients 60 years of age or older

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

24 sites in 3 countries.

24 sites in 3 countries

United States20 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Johns Hopkins University

    Baltimore, Maryland, 21218

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Massachusetts General Hospital

    Boston, Massachusetts, 20114

  • Kettering Health Network

    Centerville, Ohio, 45459

  • OrthoCarolina

    Charlotte, North Carolina, 28207

  • The MetroHealth System

    Cleveland, Ohio, 44109

  • Duke University

    Durham, North Carolina, 27710

  • University of Connecticut

    Farmington, Connecticut, 06030

  • North Shore - Long Island Jewish Health System

    Great Neck, New York, 11021

  • Norton Healthcare

    Louisville, Kentucky, 40241

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73126

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • HealthPartners Institute for Education and Research

    Saint Paul, Minnesota, 55101

  • University of Washington

    Seattle, Washington, 98104

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada3 sites

  • University of Western Ontario

    London, Ontario, N6A 4V2

  • Fraser Health Authority

    New Westminster, British Columbia, V3L 3W7

  • University of Manitoba

    Winnipeg, Manitoba

Other trials in Canada

Singapore1 site

  • National University of Singapore

    Singapore

Other trials in Singapore

About this study

Official title: 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.

Being tested
Open Reduction and Internal Fixation, External Fixation, Percutaneous Pinning, Closed Reduction and casting
Keywords
WRIST, Distal Radius Fracture, DRF, elderly, internal fixation, VLPS, External Fixation, Multi center randomized trial
Medical subject headings
Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open Reduction and Internal FixationProcedure or surgery

    Internal fixation with a volar locking plating system

  • External FixationProcedure or surgery

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

  • Percutaneous PinningProcedure or surgery

    Pinning with any number of Kirschner wires

  • Closed Reduction and castingProcedure or surgery

    Closed reduction and immobilization with a cast and/or splint

Study groups in NCT01589692
Study groupRoleWhat they receive
Internal FixationExperimentalOpen Reduction and Internal Fixation: Internal fixation with a volar locking plating system
Receives: Procedure: Open Reduction and Internal Fixation
External FixationExperimentalExternal Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
Receives: Procedure: External Fixation
PinningExperimentalPercutaneous pinning with any number of Kirschner wires
Receives: Procedure: Percutaneous Pinning
No SurgeryActive comparatorClosed Reduction and casting: Closed reduction and immobilization with a cast and/or splint
Receives: Procedure: Closed Reduction and casting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Michigan Hand Outcomes Questionnaire score

    upper-extremity questionnaire

    Measured: 12months

Secondary outcomes (4)

  1. Change in Rapid Assessment of Physical Activity score

    questionnaire

    Measured: pre-injury and 24months

  2. SF-36 score

    QOL questionnaire

    Measured: 12months

  3. complications

    Complication Checklist for Distal Radius Fracture

    Measured: 12months

  4. Hand function

    grip strength, lateral pinch strength, wrist motion

    Measured: 12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2012 (estimated)
  2. Study start10 Apr 2012
  3. Primary completion3 Feb 2018
  4. Study completion8 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01589692
Sponsor's protocol ID
R01AR062066-01A1
Other IDs
R01AR062066-01A1
Acronym
WRIST
Status last verified
Feb 2019
First submitted
25 Apr 2012
Last updated
11 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 20375760

  • 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.

    PubMed 23608306

  • 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.

    PubMed 36780156

  • 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.

    PubMed 34142664

  • 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.

    PubMed 34137830

  • 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.

    PubMed 33337492

  • 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.

    PubMed 32433648

  • 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.

    PubMed 31951273

  • 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.

    PubMed 30657531

  • 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.

    PubMed 29952895

Questions about this trial

What is this clinical trial studying?

A study testing Open Reduction and Internal Fixation, External Fixation and Percutaneous Pinning in people with Distal Radius Fracture, run by University of Michigan at 24 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Michigan Hand Outcomes Questionnaire score (time frame: 12months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01589692, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.

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