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

Study Overview
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Brief Summary
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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.

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

Conditions
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Extremity Injury

Intervention / Treatment
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* Procedure: Rigid Splint
* Procedure: Soft Dressing


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Splint<br> | Procedure: Rigid Splint<br>* 50 patients undergoing operative fixation of isolated bothbone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint.<br>|
| Active Comparator: Soft Dressing<br> | Procedure: Soft Dressing<br>* 50 patients undergoing operative fixation of isolated both bone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a soft dressing post-operatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Visual Analog Scale (VAS) | Best state you can imagine is marked 100and the worst state you can imagine is marked 0 on a line | 14 Days | 
| Percent Change in Euro Quality of Life (EQ-5D) | 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. | 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper Extremity Fracture