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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 18-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.


Detailed Summary:
Sponsor: University of Michigan

Current Primary Outcome: Change in Michigan Hand Outcomes Questionnaire score [ Time Frame: 12months ]

Original Primary Outcome: Change in Michigan Hand Outcomes Questionnaire score [ Time Frame: 6weeks, 3months, 6months, 12months, 24months ]

Current Secondary Outcome:

  • Participant Demographics [ Time Frame: baseline ]
    Participant age, income, education level, race/ethnicity will be collected to explore possible associations between outcomes and demographic factors.
  • Comorbidity [ Time Frame: baseline ]
    Participant comorbidities will be collected to explore possible associations btwn comorbidities and outcomes
  • Change in Rapid Assessment of Physical Activity score [ Time Frame: 24months ]
  • Change in SF-36 score [ Time Frame: 12months ]
  • Bone Mineral Density Testing [ Time Frame: baseline ]
    participant bone mineral density will be collected to control for the possible confounding effect of low bone mineral density
  • complications [ Time Frame: 12months ]
    frequency and type of complications will be assess to determine if particular participant or procedure factors are associated with increased complication frequency
  • Therapy compliance [ Time Frame: 6weeks ]
    Therapy compliance will be assessed to control for the possible confounding factor of low therapy compliance.
  • Change in Hand function [ Time Frame: 12months ]


Original Secondary Outcome:

  • Participant Demographics [ Time Frame: baseline ]
    Participant age, income, education level, race/ethnicity will be collected to explore possible associations between outcomes and demographic factors.
  • Comorbidity [ Time Frame: baseline ]
    Participant comorbidities will be collected to explore possible associations btwn comorbidities and outcomes
  • Change in Rapid Assessment of Physical Activity score [ Time Frame: baseline, 24months ]
  • Change in SF-36 score [ Time Frame: baseline, 2weeks, 6weeks, 3months, 6months, 12months, 24months ]
  • Bone Mineral Density Testing [ Time Frame: baseline ]
    participant bone mineral density will be collected to control for the possible confounding effect of low bone mineral density
  • complications [ Time Frame: 24months ]
    frequency and type of complications will be assess to determine if particular participant or procedure factors are associated with increased complication frequency
  • Therapy compliance [ Time Frame: 6weeks ]
    Therapy compliance will be assessed to control for the possible confounding factor of low therapy compliance.
  • Change in Hand function [ Time Frame: 6weeks, 3months, 6months, 12months, 24months ]


Information By: University of Michigan

Dates:
Date Received: April 25, 2012
Date Started: April 2012
Date Completion: April 2019
Last Updated: January 4, 2017
Last Verified: January 2017