Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?

Not Applicable

Completed

• Conditions: Extremity Injury
• Interventions: Procedure: Soft Dressing; Procedure: Rigid Splint

• Registration Number: NCT03891966
• Lead Sponsor: NYU Langone Health

Brief Summary

The goal of this study is to determine if applying a rigid splint helps to reduce pain following operative fixation of upper extremity fractures. Orthopedic trauma surgeons currently vary in their application of rigid post-operative splints versus soft dressings after certain surgical procedures based on personal preference. In this study, 100 patients undergoing operative fixation of isolated both bone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint or soft dressing post-operatively. Their pain, medication usage and function will be tracked over the 2- week postoperative period to see if splinting has any impact on outcomes.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-08
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Willing and able to participate in study and complete consent
• Will undergo operative fixation of an isolated both bone forearm, radial head, olecranon, distal humerus fracture, or humeral shaft fracture.

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Exclusion Criteria

• Pregnant women
• Patients with concomitant TBI or MR
• Polytrauma patients
• Pathologic Fractures
• Patients undergoing treatment for malignancy
• NYU SoM Students, Residents, Faculty
• Prisoners
• IV drug users or patients on chronic narcotics
• Gun shot wound victims

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soft Dressing	Soft Dressing	-
Splint	Rigid Splint	-

Primary Outcome Measures

Name	Time	Method
Percent change in Visual Analog Scale (VAS)	14 Days	Best state you can imagine is marked 100and the worst state you can imagine is marked 0 on a line
Percent Change in Euro Quality of Life (EQ-5D)	14 Days	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States