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

Primary Purpose

Radius; Fracture, Lower or Distal End

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cast made of generic plaster or fiberglass cast material
Generic "off the shelf" removable splint
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius; Fracture, Lower or Distal End focused on measuring Wrist fracture, Radius fracture, Elderly, Splint, Cast

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory Orthopaedics and Spine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Generic plaster or fiberglass cast group

Generic "off the shelf" removable splint group

Arm Description

Patients will be randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.

Subjects will be randomized and receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.

Outcomes

Primary Outcome Measures

Change in Wrist Range of Motion (ROM)
Wrist ROM will be assessed by a goniometer exam.
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.
Change in Grip Strength
Grip strength will be assessed by bilateral dynamometer testing.
Complication Rate
The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 14, 2014
Last Updated
May 19, 2017
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02066857
Brief Title
Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly
Official Title
Use of Cast Versus Removable Splints for Minimally Displaced Distal Radius Fractures in Elderly Patients: A Prospective, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius; Fracture, Lower or Distal End
Keywords
Wrist fracture, Radius fracture, Elderly, Splint, Cast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Generic plaster or fiberglass cast group
Arm Type
Active Comparator
Arm Description
Patients will be randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
Arm Title
Generic "off the shelf" removable splint group
Arm Type
Active Comparator
Arm Description
Subjects will be randomized and receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Cast made of generic plaster or fiberglass cast material
Other Intervention Name(s)
No brand name applicable.
Intervention Description
Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture.
Intervention Type
Device
Intervention Name(s)
Generic "off the shelf" removable splint
Other Intervention Name(s)
No brand name applicable
Intervention Description
Patients will be randomized to receive a generic "off the shelf" removable splint for treatment of a non-displaced distal radius fracture.
Primary Outcome Measure Information:
Title
Change in Wrist Range of Motion (ROM)
Description
Wrist ROM will be assessed by a goniometer exam.
Time Frame
Baseline, Month 3
Title
Mean Mayo Wrist Score
Description
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.
Time Frame
Baseline, Week 2, Week 6, Week 12
Title
Change in Grip Strength
Description
Grip strength will be assessed by bilateral dynamometer testing.
Time Frame
Baseline, Month 3
Title
Complication Rate
Description
The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.
Time Frame
Duration of Study (Up to 3 Months)
Title
Mean Pain Score
Description
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.
Time Frame
Baseline, Week 2, Week 6, Week 12
Secondary Outcome Measure Information:
Title
Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score
Description
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.
Time Frame
Baseline, Week 2, Week 6, Week 12
Title
Change in SF-12 QOL
Description
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.
Time Frame
Baseline, Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Colles' Fracture - Distal radius fracture with dorsal angulation, apex volar (satisfies non-operative radiographic criteria before or after reduction Isolated upper limb injury No previous wrist fracture Available for follow-up Between 60 and 100 years of age Exclusion Criteria: Less than 60 years of age Fractures that do not meet non-operative criteria or are deemed unstable by surgeon, subsequently requiring surgery after first clinic visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudius Jarrett, M.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Orthopaedics and Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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