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

Radius; Fracture, Lower or Distal End Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066857
• Other study ID #: IRB00071060
• Status: Completed
• Phase: N/A
• First received: February 14, 2014
• Last updated: May 19, 2017
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fractures
• Radius; Fracture, Lower or Distal End

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory Orthopaedics and Spine Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Wrist Range of Motion (ROM)	Wrist ROM will be assessed by a goniometer exam.	Baseline, Month 3
Primary	Mean Mayo Wrist Score	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
Primary	Change in Grip Strength	Grip strength will be assessed by bilateral dynamometer testing.	Baseline, Month 3
Primary	Complication Rate	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)
Primary	Mean Pain Score	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	Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score	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
Secondary	Change in SF-12 QOL	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