Back to resultsA Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly
Primary Purpose
Distal Radius Fracture
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wrist Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture
Eligibility Criteria
Inclusion Criteria:
- Patients greater than 65 years old with isolated distal radius fracture amenable to non-operative treatment
Exclusion Criteria:
- Patients younger than 65 years old
- Open fractures (Gustilo Grade 2 or 3)
- Pathologic fractures
- Multiple fractures in the upper or lower extremities
- Fracture indicated for surgical repair of the distal radius for any reason
- Lack of health insurance
- Inability to provide consent to the study
Sites / Locations
- Rothman Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Cast Group
Splint Group
Arm Description
participant with distal radius fracture will be treated with short arm fiberglass cast
participant with distal radius fracture will be treated with short arm velcro wrist splint
Outcomes
Primary Outcome Measures
Fracture treatment outcome
The rate of successful outcomes of participants who are treated for a distal radius fracture nonsurgically by splinting compared to participants who are treated by casting
Secondary Outcome Measures
Full Information
NCT ID
NCT04632745
First Posted
October 29, 2020
Last Updated
November 11, 2020
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT04632745
Brief Title
A Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly
Official Title
A Prospective Randomized Evaluation of Splinting and Casting for Distal Radius Fractures in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2020 (Anticipated)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Distal radial fractures are the most common fracture of the upper extremity in adults, with a higher incidence in those 65 years of age or older. In 2009, Karl et al demonstrated that there are 25.42 distal radial fractures in this age group per 10,000 person-years in the US. Despite the frequency of distal radius fractures, there is still debate over the best method of treatment. In contrast to younger patients, patients who are 65 years or older appear to have acceptable functional outcomes and treatment satisfaction regardless of the presence of malalignment on radiographic imaging.Therefore, nonsurgical management has been shown to be a viable treatment option.
The purpose of this study is to compare non-operative treatment with a removable splint versus a short arm cast for distal radial fractures in patients who are 65 years of age or older who are indicated for non-operative fracture treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cast Group
Arm Type
Other
Arm Description
participant with distal radius fracture will be treated with short arm fiberglass cast
Arm Title
Splint Group
Arm Type
Other
Arm Description
participant with distal radius fracture will be treated with short arm velcro wrist splint
Intervention Type
Other
Intervention Name(s)
Wrist Rehabilitation
Intervention Description
participants will undergo immobilization for the first 6 weeks of treatment
Primary Outcome Measure Information:
Title
Fracture treatment outcome
Description
The rate of successful outcomes of participants who are treated for a distal radius fracture nonsurgically by splinting compared to participants who are treated by casting
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients greater than 65 years old with isolated distal radius fracture amenable to non-operative treatment
Exclusion Criteria:
Patients younger than 65 years old
Open fractures (Gustilo Grade 2 or 3)
Pathologic fractures
Multiple fractures in the upper or lower extremities
Fracture indicated for surgical repair of the distal radius for any reason
Lack of health insurance
Inability to provide consent to the study
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly
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