Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03891966|
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Extremity Injury||Procedure: Rigid Splint Procedure: Soft Dressing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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
- 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.
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
|Contact: Erin Kelly||646 501 0291||Kelly.Doran@nyulangone.org|
|United States, New York|
|NYU Langone Health||Recruiting|
|New York, New York, United States, 10016|
|Contact: Erin Kelly 646-501-0291 email@example.com|
|Principal Investigator: Philipp Leucht, MD|
|Principal Investigator:||Philipp Leucht, MD||New York Langone Medical Center|