Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly

May 19, 2017 updated by: Claudius Jarrett, Emory University

Use of Cast Versus Removable Splints for Minimally Displaced Distal Radius Fractures in Elderly Patients: A Prospective, Randomized Trial

The purpose of this prospective randomized study is to add to the body of knowledge on the treatment of minimally displaced distal radius fractures in patients over 60 years of age. The investigators believe that treating minimally displaced distal radius fractures in people over 60 with a removable splint and early range of motion will provide greater patient satisfaction, fewer complications, and earlier functional returns to pre-injury for these patients compared to those treated with a short arm cast which immobilizes the limb for at least four weeks, and has been shown to lead to longer recovery and possible residual stiffness. The investigators hope to provide sufficient evidence in directing treatment that will give the most efficacious and the most satisfactory return of prior function to patients. Since distal radius fractures in the elderly are common because of poorer bone quality, the elderly proportion of the population is increasing, and controlling health costs is of current concern, answering the question of which treatment produces the best results for all these concerns is of increasing importance now.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory Orthopaedics and Spine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Colles' Fracture - Distal radius fracture with dorsal angulation, apex volar (satisfies non-operative radiographic criteria before or after reduction
  2. Isolated upper limb injury
  3. No previous wrist fracture
  4. Available for follow-up
  5. Between 60 and 100 years of age

Exclusion Criteria:

  1. Less than 60 years of age
  2. Fractures that do not meet non-operative criteria or are deemed unstable by surgeon, subsequently requiring surgery after first clinic visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Generic plaster or fiberglass cast group
Patients will be randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
Device: Cast made of generic plaster or fiberglass cast material
Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture.
Other Names:
  • No brand name applicable.
Active Comparator: Generic "off the shelf" removable splint group
Subjects will be randomized and receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.
Device: Generic "off the shelf" removable splint
Patients will be randomized to receive a generic "off the shelf" removable splint for treatment of a non-displaced distal radius fracture.
Other Names:
  • No brand name applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Wrist Range of Motion (ROM)
Time Frame: Baseline, Month 3
Wrist ROM will be assessed by a goniometer exam.
Baseline, Month 3
Mean Mayo Wrist Score
Time Frame: Baseline, Week 2, Week 6, Week 12
The Mayo Wrist Score is a clinician-completed scoring system used to evaluate the level of functionality in the wrist, assessing pain, functional status (able to work), range of motion and grip strength. Total scores for functionality range from 0-100 and are categorized as follows: 90-100 indicates excellent, 80-90 indicates good, 60-80 indicates satisfactory, below 60 indicates poor. The assessment was completed at all study visits.
Baseline, Week 2, Week 6, Week 12
Change in Grip Strength
Time Frame: Baseline, Month 3
Grip strength will be assessed by bilateral dynamometer testing.
Baseline, Month 3
Complication Rate
Time Frame: Duration of Study (Up to 3 Months)
The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.
Duration of Study (Up to 3 Months)
Mean Pain Score
Time Frame: Baseline, Week 2, Week 6, Week 12
Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing "no pain" and 10 representing "the worst pain imaginable". The assessment was completed at all study visits.
Baseline, Week 2, Week 6, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score
Time Frame: Baseline, Week 2, Week 6, Week 12
The DASH questionnaire asks about symptoms as well as ability to perform certain activities. Scores range on a 0-100 scale. A higher score indicates greater disability.
Baseline, Week 2, Week 6, Week 12
Change in SF-12 QOL
Time Frame: Baseline, Month 3
The SF-12 QOL is a self-administered measure asking views about participant's health and how well they are able to perform usual activities.
Baseline, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Claudius Jarrett, M.D., Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00071060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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