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NCT Number: NCT07495618

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

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kormed Casa Di Cura San Camillo

Forte dei Marmi, LUCCA, 55042, Italy

Location contact

GIOVANNI PELLICCIA, MD

CONTACT

[email protected]

0039 3480364112

Giovanni Pelliccia, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Surgeon Energy Expenditure (kcal)

    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).

Secondary outcomes

  1. Surgeon Heart Rate (BPM)

    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

  2. Minute Ventilation (mL/min)

    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

Other outcomes

  1. Operative Time (Minutes)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacopo Conteduca, MD

CONTACT

[email protected]

0039. 3332280645

Sponsors and collaborators

Lead sponsor

ASL Lecce

Other Gov

Registry information

Acronym: UKA-STRESS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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