Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures
Primary Purpose
Radius Fractures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sugar Tong Splint
Clam Shell Splint
Sponsored by
About this trial
This is an interventional treatment trial for Radius Fractures focused on measuring acute, displaced distal radius fracture
Eligibility Criteria
Inclusion Criteria:
- acute, displaced distal radius fracture
- isolated injury
Exclusion Criteria:
- polytrauma
- non-displaced fracture
- prior wrist fracture
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sugartong Splint
Clam Shell Splint
Arm Description
Outcomes
Primary Outcome Measures
Displacement of fracture, measured by radial height
>2 mm of radial height lost from immediate post-reduction radiographs
A t-test will be performed with a p value < 0.05 to determine significance in loss of reduction A t-test will also be performed comparing individual parameters between the 2 splinting methods
Displacement of fracture, measured by volar tilt
> 5 degrees of radial inclination lost from immediate post-reduction radiographs
A t-test will be performed with a p value < 0.05 to determine significance in loss of reduction A t-test will also be performed comparing individual parameters between the 2 splinting methods
Displacement of fracture, measured by radial inclination
> 10 degrees of volar tilt lost from immediate post-reduction radiographs
A t-test will be performed with a p value < 0.05 to determine significance in loss of reduction A t-test will also be performed comparing individual parameters between the 2 splinting methods
Disabilities of the Arm, Shoulder,and Hand (DASH) outcome score
30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03570905
Brief Title
Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures
Official Title
Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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
Subjects with acute, displaced distal radius fractures will be randomized at the time of emergency room evaluation to one of two commonly accepted splinting methods for displaced distal radius fractures: sugar tong splints or volar/dorsal clam shell splints. Reduction will be performed in the usual, standard fashion and the selected splint applied. Standard radiographic measurements of alignment, including radial height, volar tilt and inclination will be measured on pre- and post- reduction radiographs by a single reviewer- who will be blinded to splint application type. At the first fracture follow-up visit, typically occurring between 5-10 days, as in standard practice, repeat radiographs of the wrist will be taken, and the same reviewer will measure alignment. As a secondary outcome, patients will also complete the disabilities of the arm, shoulder and hand (DASH) questionnaire at this visit, to compare patients' ability to perform activities of daily living with their respective splints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fractures
Keywords
acute, displaced 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
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugartong Splint
Arm Type
Experimental
Arm Title
Clam Shell Splint
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Sugar Tong Splint
Intervention Description
A splint made of 8-10 layers of plaster rolled into a single long sheet which begins at the distal volar crease of the hand and traverses around the elbow and stops at the dorsal metacarpal heads. The skin is protected with cotton cast padding (webril) and the splint is held in place with ace bandages
Intervention Type
Other
Intervention Name(s)
Clam Shell Splint
Intervention Description
A 2-part splint made of 8-10 layers of plaster. The piece traverses from the distal volar crease of the hand to the volar aspect of the proximal forearm. The second piece runs along the dorsal aspect of forearm from metacarpal heads to proximal forearm. The elbow is left free. In the same fashion as the sugar tong splint, the skin is protected with cotton cast padding (webril) and held in place with ace wrap
Primary Outcome Measure Information:
Title
Displacement of fracture, measured by radial height
Description
>2 mm of radial height lost from immediate post-reduction radiographs
A t-test will be performed with a p value < 0.05 to determine significance in loss of reduction A t-test will also be performed comparing individual parameters between the 2 splinting methods
Time Frame
1 Week
Title
Displacement of fracture, measured by volar tilt
Description
> 5 degrees of radial inclination lost from immediate post-reduction radiographs
A t-test will be performed with a p value < 0.05 to determine significance in loss of reduction A t-test will also be performed comparing individual parameters between the 2 splinting methods
Time Frame
1 Week
Title
Displacement of fracture, measured by radial inclination
Description
> 10 degrees of volar tilt lost from immediate post-reduction radiographs
A t-test will be performed with a p value < 0.05 to determine significance in loss of reduction A t-test will also be performed comparing individual parameters between the 2 splinting methods
Time Frame
1 Week
Title
Disabilities of the Arm, Shoulder,and Hand (DASH) outcome score
Description
30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Time Frame
1 Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute, displaced distal radius fracture
isolated injury
Exclusion Criteria:
polytrauma
non-displaced fracture
prior wrist fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirmal Tejwani
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication. Researchers who provide a methodologically sound proposal will have access.
IPD Sharing Access Criteria
Requests should be directed to nicole.stevens@nyumc.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures
We'll reach out to this number within 24 hrs