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NCT06180044 Clinical Trial

Physiologic Burden to the Surgeon During Orthopaedic Surgery

Physiological Stress Clinical Trial

Official title:
Quantification of Physiologic Burden to the Surgeon During Orthopaedic Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06180044
Other study ID # 170873
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 28, 2023
Est. completion date November 2026

Study information
Verified date December 2023
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigator's plan to quantify the physiologic impact of orthopaedic surgery on the surgeon and operating team.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 20
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Utah Orthopedics Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Average Heart Rate (beats per minute, bpm) Average surgeon heart rate prior to surgery. 30 minutes before surgery
Primary Average Heart Rate (beats per minute, bpm) Average surgeon heart rate during surgery. During entire surgical procedure
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