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

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT03891966
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
60
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Rigid Splint
  • Procedure: Soft Dressing
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?
Actual Study Start Date :
Nov 8, 2018
Anticipated Primary Completion Date :
Nov 8, 2023
Anticipated Study Completion Date :
Nov 8, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Splint

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.
Active Comparator: Soft Dressing

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Philipp Leucht, MD, New York Langone Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03891966
Other Study ID Numbers:
  • 18-01505
First Posted:
Mar 27, 2019
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by NYU Langone Health
Upper Extremity Fracture
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Jan 21, 2022