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

NCT01118715 | Terminated Results

• 1 other identifier: DRF-001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

distal radius fracture; post-traumatic carpal tunnel syndrome; complex regional pain syndrome; compression glove; edema glove

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)

  Confirmed cases of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)

  2 wks-24 wks

Secondary Outcomes (5)

• Edema

  2 wks- 24 weeks

• Range of Motion

  2 wks-24 wks

• Grip Strength

  5 wks-24 wks

• DASH Score

  2 wks- 24 wks

• Pain on Numerical Rating Scale

  2 wks- 24 wks

Study Arms (2)

Compression glove

EXPERIMENTAL

Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal.

Device: Compression glove

Control

NO INTERVENTION

Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.

Interventions

Compression glove DEVICE

A compression glove worn during recovery from distal radius fracture

Compression glove

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Between the ages of 18-85
• Patients with unstable unilateral distal radius fractures (requiring surgical stabilization)

You may not qualify if:

• 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.

Sponsors & Collaborators

• J&M Shuler: lead

Study Sites (1)

Athens Orthopedic Clinic

Athens, Georgia, 30606, United States

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Edema; Wrist Fractures

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Results Point of Contact

• Title: Dr. Michael Shuler
• Organization: Athens Orthopedic Clinic

mshuler@athensorthopedicclinic.com

706-549-1663

Study Officials

• Michael S Shuler, MD

  J&M Shuler

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hand and Upper Extremity Specialist

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 7, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2017
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-10

Locations

US (1)