Kormed Casa Di Cura San Camillo
Forte dei Marmi, LUCCA, 55042, Italy
Location contact
GIOVANNI PELLICCIA, MD
CONTACT
Giovanni Pelliccia, MD
SUB_INVESTIGATOR
NCT Number: NCT07495618
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.
Trial opening soon.
Get Notified18 year–95 year
All sexes
Observational
Forte dei Marmi, LUCCA, 55042, Italy
GIOVANNI PELLICCIA, MD
CONTACT
Giovanni Pelliccia, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: intraoperative. (measured continuously from surgical draping to wound closure)
Total time elapsed from the first incision to final skin closure. This is a critical variable as energy expenditure is often adjusted for the length of the case.
Contact information is provided by the study sponsor or research team.
ASL Lecce
Other Gov
Acronym: UKA-STRESS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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