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

NCT07495618 · tracked via the Priya Life Science Italy tracker
Sponsor
Phase
Observational
Started
2026-03-20
Last updated
2026-03-27

Condition(s) studied

Surgeon Physiologic Stress

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
Kormed Casa Di Cura San Camillo Forte dei Marmi LUCCA
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07495618 on ClinicalTrials.gov ↗ ← All trials in Italy