- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06180044
Physiologic Burden to the Surgeon During Orthopaedic Surgery
Quantification of Physiologic Burden to the Surgeon During Orthopaedic Surgery
Study Overview
Status
Conditions
Detailed Description
The prevalence of musculoskeletal pain among orthopaedic surgeons is inordinately high. Poor surgical ergonomics and physiological stress have been shown to impair surgical performance and cause injuries. Various approaches, techniques and instruments have been designed to improve surgical outcomes for patients. There has been nominal research in the area of occupational hazards such surgeries impose upon the surgeon. Several studies have demonstrated a higher risk of cervical spondylosis and rotator cuff tears amongst surgeons. However, little has been studied on the impacts of some of these approaches, techniques, and instruments on surgeons' physiologic measures.
The investigator's will use The Hexoskin Smart Vest to capture physiological data from surgeons during the study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- University of Utah Orthopedics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Orthopaedic surgeons, orthaopedic fellows, and orthopaedic residents.
- Up to 750 surgical patients of the participating surgeons will be included for demographic chart review.
Exclusion Criteria:
- Non-surgeons, fellows, or residents.
- Female participants that are or become pregnant.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Heart Rate (beats per minute, bpm)
Time Frame: 30 minutes before surgery
|
Average surgeon heart rate prior to surgery.
|
30 minutes before surgery
|
|
Average Heart Rate (beats per minute, bpm)
Time Frame: During entire surgical procedure
|
Average surgeon heart rate during surgery.
|
During entire surgical procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher Pelt, M.D., University of Utah
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 170873
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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