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

This study is currently Recruiting

June 2011 By J&M Shuler

First Recieved on April 30, 2010

Last Updated on June 14, 2011

Sponsor: J&M Shuler
Collaborators:
Information provided by: J&M Shuler
Identifier: NCT01118715

Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Male or female - Between the ages of 18-85 - Patients with unstable unilateral distal radius fractures (requiring surgical stabilization) Exclusion Criteria: - Pre-existing cases of carpal tunnel syndrome and/or complex regional pain syndrome - Nerve or tendon laceration - Decompression of carpal tunnel concomitant with surgical stabilization - Additional fractures, including carpal fractures, more proximal fractures of the radius, and finger injuries will be excluded from the study (Ulnar styloid and ulnar head and neck fractures will be included) - Uncontrolled rheumatoid arthritis patients - Bilateral fractures - Unable or unwilling to provide written informed consent.

Investigators

  • Investigator: Michael S Shuler, MD - Principal Investigator - J&M Shuler

Locations

  • Athens Orthopedic Clinic

    Athens, Georgia 30606 United States

Conditions related to this trial:

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