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

NCT03891966 | Completed

• 1 other identifier: 18-01505
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Extremity Injury

Keywords

Upper Extremity Fracture

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Splint

ACTIVE COMPARATOR

Procedure: Rigid Splint

Soft Dressing

ACTIVE COMPARATOR

Procedure: Soft Dressing

Interventions

Rigid Splint PROCEDURE

50 patients undergoing operative fixation of isolated bothbone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint.

Splint

Soft Dressing PROCEDURE

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.

Soft Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• Sgaglione MW, Solasz SJ, Leucht P, Egol KA. Is Postoperative Splinting Advantageous After Upper Extremity Fracture Surgery? Results From the Arm Splint Pain Improvement Research Experiment. J Orthop Trauma. 2024 Mar 1;38(3):e92-e97. doi: 10.1097/BOT.0000000000002742.

  PMID: 38117579 DERIVED

Study Officials

• Philipp Leucht, MD

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 27, 2019
• Study Start: November 8, 2018
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: Requests should be directed to Philipp.Leucht@nyulangone.org To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)