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

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.

Study Overview

• Status: Completed
• Conditions: Radius Fractures
• Intervention / Treatment: Other: Sugar Tong Splint; Other: Clam Shell Splint

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• acute, displaced distal radius fracture
• isolated injury

Exclusion Criteria:

• polytrauma
• non-displaced fracture
• prior wrist fracture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugartong Splint	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
Experimental: Clam Shell Splint	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Nirmal Tejwani, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: acute, displaced distal radius fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 17-01697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No