NCT07495618

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: ASL Lecce · Other Government
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgeon Physiologic Stress

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Italy