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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03570905
Enrollment
87
Registered
2018-06-27
Start date
2019-12-01
Completion date
2020-12-31
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radius Fractures

Keywords

acute, displaced distal radius fracture

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.

Interventions

OTHERSugar 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

OTHERClam 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

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* acute, displaced distal radius fracture * isolated injury

Exclusion criteria

* polytrauma * non-displaced fracture * prior wrist fracture

Design outcomes

Primary

MeasureTime frameDescription
Displacement of fracture, measured by radial height1 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 volar tilt1 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 inclination1 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 score1 Week30-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026