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Completed

NCT Number: NCT03570905

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acute, displaced distal radius fracture
  • isolated injury

Exclusion criteria

  • polytrauma
  • non-displaced fracture
  • prior wrist fracture

Treatment and study plan

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

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

Primary outcomes

  1. Displacement of fracture, measured by radial height

    Time frame: 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

  2. Displacement of fracture, measured by volar tilt

    Time frame: 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

  3. Displacement of fracture, measured by radial inclination

    Time frame: 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

  4. Disabilities of the Arm, Shoulder,and Hand (DASH) outcome score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 27, 2018
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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