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

NCT03570905 | Completed

• 1 other identifier: 17-01697
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Radius Fractures

Keywords

acute, displaced distal radius fracture

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Sugartong Splint

EXPERIMENTAL

Other: Sugar Tong Splint

Clam Shell Splint

EXPERIMENTAL

Other: Clam Shell Splint

Interventions

Sugar Tong Splint OTHER

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

Sugartong Splint

Clam Shell Splint OTHER

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

Clam Shell Splint

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute, displaced distal radius fracture
• isolated injury

You may not qualify if:

• polytrauma
• non-displaced fracture
• prior wrist fracture

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Radius Fractures

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Nirmal Tejwani

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 27, 2018
• Study Start: December 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication. Researchers who provide a methodologically sound proposal will have access.
• Access Criteria: Requests should be directed to nicole.stevens@nyumc.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)