Back to resultsUpper Extremity Post-op Splints: Do They Improve Post-operative Pain?
Primary Purpose
Extremity Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rigid Splint
Soft Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Extremity Injury focused on measuring Upper Extremity Fracture
Eligibility Criteria
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
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Splint
Soft Dressing
Arm Description
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03891966
Brief Title
Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?
Official Title
Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
November 8, 2023 (Anticipated)
Study Completion Date
November 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extremity Injury
Keywords
Upper Extremity Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Splint
Arm Type
Active Comparator
Arm Title
Soft Dressing
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Rigid Splint
Intervention Description
50 patients undergoing operative fixation of isolated bothbone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint.
Intervention Type
Procedure
Intervention Name(s)
Soft Dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent change in Visual Analog Scale (VAS)
Description
Best state you can imagine is marked 100and the worst state you can imagine is marked 0 on a line
Time Frame
14 Days
Title
Percent Change in Euro Quality of Life (EQ-5D)
Description
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.
Time Frame
14 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Leucht, MD
Phone
(212) 598-6000
Email
philipp.leucht@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Leucht, MD
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Leucht, MD
Phone
212-598-6000
Email
philipp.leucht@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Philipp Leucht, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
Requests should be directed to Philipp.Leucht@nyulangone.org To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?
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