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

Extremity Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891966
• Other study ID #: 18-01505
• Status: Completed
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extremity Injury
• Pain, Postoperative

Intervention

Procedure:
• Rigid Splint
50 patients undergoing operative fixation of isolated bothbone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint.
• Soft Dressing
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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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