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Trial record 76 of 582 for:    Recruiting, Not yet recruiting, Available Studies | Superior

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

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ClinicalTrials.gov Identifier: NCT03891966
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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
Extremity Injury Procedure: Rigid Splint Procedure: Soft Dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 8, 2018
Estimated Primary Completion Date : November 8, 2023
Estimated Study Completion Date : November 8, 2023

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.




Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891966


Contacts
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Contact: Erin Kelly 646 501 0291 Kelly.Doran@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Erin Kelly    646-501-0291    erin.kelly@nyulangone.org   
Principal Investigator: Philipp Leucht, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Philipp Leucht, MD New York Langone Medical Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03891966     History of Changes
Other Study ID Numbers: 18-01505
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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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:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms