Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Percent change in Visual Analog Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Splint
Intervention: Rigid Splint (Procedure)
Soft Dressing
Intervention: Soft Dressing (Procedure)
Outcomes
Primary Outcomes
Percent change in Visual Analog Scale (VAS)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported