Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures

Not Applicable

Completed

• Conditions: Radius Fractures
• Interventions: Other: Sugar Tong Splint; Other: Clam Shell Splint

• Registration Number: NCT03570905
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-27
• Study Start: 2019-12-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• acute, displaced distal radius fracture
• isolated injury

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Exclusion Criteria

• polytrauma
• non-displaced fracture
• prior wrist fracture

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugartong Splint	Sugar Tong Splint	-
Clam Shell Splint	Clam Shell Splint	-

Primary Outcome Measures

Name	Time	Method
Displacement of fracture, measured by volar tilt	1 Week	\> 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 height	1 Week	\>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 radial inclination	1 Week	\> 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	1 Week	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States