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

Radius Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570905
• Other study ID #: 17-01697
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• acute, displaced distal radius fracture
• isolated injury

Exclusion Criteria:

• polytrauma
• non-displaced fracture
• prior wrist fracture

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fractures

Intervention

Other:
• Sugar Tong Splint
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
• Clam Shell Splint
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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 Week
Primary	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	1 Week
Primary	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	1 Week
Primary	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.	1 Week