NCT06180044

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
18mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Nov 2023Nov 2027

Study Start

First participant enrolled

November 28, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

3.9 years

First QC Date

December 12, 2023

Last Update Submit

November 17, 2025

Conditions

Physiological Stress

Keywords

SurgeonOrthopaedic surgeryHexoskin Smart VestPhysiologic data

Outcome Measures

Primary Outcomes (2)

  • Average Heart Rate (beats per minute, bpm)

    Average surgeon heart rate prior to surgery.

    30 minutes before surgery

  • Average Heart Rate (beats per minute, bpm)

    Average surgeon heart rate during surgery.

    During entire surgical procedure

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Orthopaedic surgeons, orthopaedic fellows, and orthopaedic residents performing surgery.

You may qualify if:

  • Orthopaedic surgeons, orthaopedic fellows, and orthopaedic residents.
  • Up to 750 surgical patients of the participating surgeons will be included for demographic chart review.

You may not qualify if:

  • Non-surgeons, fellows, or residents.
  • Female participants that are or become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

Study Officials

  • Christopher Pelt, M.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 22, 2023

Study Start

November 28, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

US(1)