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Surgeon Physiologic Stress During Unicompartmental Knee Arthroplasty: Manual vs Computer-Assisted Technique

Surgeon Physiologic Stress During Unicompartmental Knee Arthroplasty: Manual vs Computer-Assisted Technique

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07495618
Acronym
UKA-STRESS
Enrollment
80
Registered
2026-03-27
Start date
2026-03-20
Completion date
2027-04-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgeon Physiologic Stress

Keywords

Unicompartmental Knee Arthroplasty, Knee Osteoarthritis, Surgeon Physiologic Demand

Brief summary

This study aims to compare the physiologic stress experienced by the surgeon during unicompartmental knee arthroplasty (UKA) performed using a manual technique versus a computer-assisted technique. Surgeon physiologic parameters, including energy expenditure, heart rate, heart rate variability, and minute ventilation, will be measured intraoperatively using a wearable monitoring device (Hexoskin). The study seeks to determine whether computer-assisted surgery influences surgeon workload compared to the conventional manual approach.

Detailed description

Unicompartmental knee arthroplasty (UKA) is a widely performed surgical procedure for the treatment of unicompartmental knee osteoarthritis. Surgical techniques for UKA include conventional manual instrumentation and computer-assisted approaches, including navigation and robotic systems. While previous studies have evaluated clinical outcomes and implant positioning, limited data exist regarding the physiologic demands placed on the surgeon during these procedures. Recent evidence has demonstrated that surgeon physiologic stress, including energy expenditure and cardiovascular parameters, can be objectively measured using wearable monitoring devices during total knee arthroplasty. However, no studies have specifically evaluated these parameters in the setting of UKA or compared manual and computer-assisted techniques. The aim of this study is to prospectively evaluate and compare the physiologic workload of the surgeon during UKA performed using manual versus computer-assisted techniques. Surgeon physiologic parameters, including energy expenditure (kcal), heart rate (beats per minute), heart rate variability, and minute ventilation, will be continuously recorded intraoperatively using a validated wearable device (Hexoskin). Patient demographic and surgical variables, including age, body mass index, and operative time, will also be collected to account for potential confounding factors. Statistical analysis will be performed to compare physiologic parameters between the two surgical techniques, with adjustment for relevant covariates. The results of this study may provide objective data regarding surgeon workload and may contribute to a better understanding of the impact of surgical technology on operative demand and ergonomics.

Interventions

None listed

Sponsors

ASL Lecce
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* primary, elective unicompartmental knee arthroplasty (UKA). * Clinical and radiographic evidence of symptomatic unicompartmental knee osteoarthritis. * Candidates for either manual or computer-assisted/robotic cemented UKA. * Procedures performed by fellowship-trained arthroplasty surgeons to ensure technical consistency. * Patients willing and able to provide informed consent for the collection of perioperative data.

Exclusion criteria

* Revision Surgery: Patients undergoing revision knee arthroplasty (as the study focuses on primary cases). * Complex Scars: Presence of significant prior knee surgery or hardware that may abnormally increase surgical difficulty. * Inflammatory Arthritis: Patients with inflammatory conditions like rheumatoid arthritis (optional, depending on your focus). * Non-elective or trauma-related knee procedures. * Surgeon Limitation: Any physical condition of the participating surgeon that prevents the use of the wearable monitoring garment.

Design outcomes

Primary

MeasureTime frameDescription
Surgeon Energy Expenditure (kcal)intraoperative (measured continuously from surgical draping to wound closure)The total metabolic energy consumed by the surgeon during the surgical procedure, measured in kilocalories (kcal).

Secondary

MeasureTime frameDescription
Surgeon Heart Rate (BPM)intraoperative. (measured continuously from surgical draping to wound closure)The average and peak heart rate of the surgeon, measured in beats per minute (BPM) to assess cardiovascular stress
Minute Ventilation (mL/min)intraoperative. (measured continuously from surgical draping to wound closure)The volume of gas inhaled or exhaled from the surgeon's lungs per minute, used as an indicator of respiratory effort and physical exertion

Countries

Italy

Contacts

CONTACTJacopo Conteduca, MD
CONTEDUCA85@GMAIL.COM0039. 3332280645

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026