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Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial

NCT01118715 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2020-11-04

Study results available
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Summary

Distal radius fractures (DRF) are the most common type of fracture in the human body, and a large proportion of DRFs result in complications. Previously proposed preventive strategies have questionable efficacy and may impose additional risks on the patient. Because many complications secondary to distal radius fractures are associated with excessive swelling, a prophylactic means for edema reduction could dramatically reduce morbidity among this population. A compression glove is a non-invasive, non-pharmacological way to reduce edema. Previous studies have confirmed its utility in edema reduction after hand trauma and among patients with chronic inflammatory conditions, but none have sufficiently investigated the application to patients with distal radius fractures, a population in which this intervention could have a large impact. The investigators propose a randomized controlled trial to evaluate use of a compression glove during recovery among patients who have sustained an unstable distal radius fracture. The investigators hypothesize that patients who wear a compression glove after a distal radius fracture:

* Will experience less edema
* Will demonstrate greater functionality
* Will recover more quickly
* Will have lower incidence rates of carpal tunnel syndrome
* Will have lower incidence rates of complex regional pain syndrome

Conditions

  • Post-traumatic Carpal Tunnel Syndrome
  • Complex Regional Pain Syndrome
  • Edema

Interventions

DEVICE

Compression glove

A compression glove worn during recovery from distal radius fracture

Sponsors & Collaborators

  • J&M Shuler

    lead INDUSTRY

Principal Investigators

  • Michael S Shuler, MD · J&M Shuler

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-12-31
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01118715 on ClinicalTrials.gov