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Short Forearm Casting Versus Below-elbow Splinting for Acute Immobilization of Distal Radius Fractures

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ClinicalTrials.gov Identifier: NCT02679066
Recruitment Status : Terminated (lack of consistent enrollment, follow up and results)
First Posted : February 10, 2016
Results First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

There is no consensus regarding the need to immobilize the elbow in immediate immobilization of closed distal radius fractures post-reduction. Decreased functionality of the upper extremity is a notable morbidity associated with below-elbow splinting of distal radius fractures post-reduction. Few studies have provided evidence comparing sugar tong splinting versus short-arm casting as methods of immediate post-reduction immobilization. The study will randomize patients with close distal radius fractures to short forearm casting versus sugar tong splinting with close follow up including radiographic and clinical evaluation.

This will provide guidance regarding the need for short forearm cast immobilization versus sugar tong splinting in early maintenance of reduction of closed distal radius fractures, as well as functional effects of sugar tong splinting versus short forearm casting.


Condition or disease Intervention/treatment Phase
Distal Radius Fracture Device: Sugar-tong splint Device: Short forearm cast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Forearm Casting Versus Below-elbow Splinting for Acute Immobilization of Distal Radius Fractures
Actual Study Start Date : January 2014
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sugar-tong splint
Patients are placed in a sugar-tong splint for immobilization of the distal radius fracture.
Device: Sugar-tong splint
Plaster immobilization including the elbow

Active Comparator: Short Forearm Cast
Patients are placed in a short forearm cast, with bivalve, for immobilization of the distal radius fracture.
Device: Short forearm cast
Fiberglass immobilization with elbow free




Primary Outcome Measures :
  1. Number of Participants With Maintenance of Reduction [ Time Frame: one month ]
    Radiologic parameters to include radial height, radial inclination and volar tilt will be measured from post-immobilization radiographs at presentation, one week, two weeks and four weeks. Maintenance of reduction will be defined as: loss of reduction of < 2 mm radial height, < 5 degrees of radial inclination or < 10 degrees of volar tilt and/or < 2 mm intra-articular step off, in follow up radiographs as compared to immediate post-reduction radiographs.


Secondary Outcome Measures :
  1. Disabilities of the Arm, Shoulder and Hand (DASH) Score - Upper Extremity Function [ Time Frame: Two weeks ]
    This is a validated survey of upper extremity function that is administered at the two week follow up visit. The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult > 18 years of age
  • Closed fracture
  • Isolated injury
  • No prior injury to ipsilateral forearm
  • Less than or equal to two attempts at reduction

Exclusion Criteria:

  • Ipsilateral upper extremity injury
  • Open injury or neurovascular compromise
  • Greater than two attempts at reduction
  • Presentation greater than 24 hours after injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679066


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Erik Hasenboehler, MD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02679066    
Other Study ID Numbers: IRB00087273
First Posted: February 10, 2016    Key Record Dates
Results First Posted: March 25, 2020
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries