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

Not Applicable

Completed

• Conditions: Radius; Fracture, Lower or Distal End
• Interventions: Device: Generic "off the shelf" removable splint; Device: Cast made of generic plaster or fiberglass cast material

• Registration Number: NCT02066857
• Lead Sponsor: Emory University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-20
• Study Start: 2014-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2017-03-31
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-19
• Last Update Submitted: 2017-05-19
• Results First Posted: 2017-05-24
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Generic "off the shelf" removable splint group	Generic "off the shelf" removable splint	Subjects will be randomized and receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.
Generic plaster or fiberglass cast group	Cast made of generic plaster or fiberglass cast material	Patients will be randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Wrist Range of Motion (ROM)	Baseline, Month 3	Wrist ROM will be assessed by a goniometer exam.
Mean Mayo Wrist Score	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.
Change in Grip Strength	Baseline, Month 3	Grip strength will be assessed by bilateral dynamometer testing.
Complication Rate	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.
Mean Pain Score	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.

Secondary Outcome Measures

Name	Time	Method
Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score	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.
Change in SF-12 QOL	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.

Trial Locations

Locations (1)

Emory Orthopaedics and Spine Center; 🇺🇸 Atlanta, Georgia, United States