Surgeon Physiologic StressUKA-STRESSNCT07495618
Surgeon Physiologic Stress During Unicompartmental Knee Arthroplasty: Manual vs Computer-Assisted Technique
An observational study of Surgeon Physiologic Stress, run by ASL Lecce at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Surgeon Physiologic Stress
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2026to Apr 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the study population consists of adult patients scheduled for elective, primary unicompartmental knee arthroplasty (UKA) at a high-volume orthopedic specialty center. This population includes individuals with symptomatic knee osteoarthritis limited to a single compartment (medial or lateral) who have failed conservative management. The cohort represents a broad range of body mass index (BMI) scores and age groups, reflecting the typical demographic of patients seeking partial knee replacement. Participants are selected based on the surgeon's clinical decision to utilize either a manual technique or a computer-assisted/robotic system, allowing for a real-world observational comparison of surgical physical demand.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Kormed Casa Di Cura San Camillo
Forte dei Marmi, LUCCA, 55042
GIOVANNI PELLICCIA, MD, 0039 3480364112, juanpellix@gmail.com
Giovanni Pelliccia, MD
About this study
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.
Read the 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
- Keywords
- Unicompartmental Knee Arthroplasty, Knee Osteoarthritis, Surgeon Physiologic Demand
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Manual Technique UKA group | This cohort consists of patients undergoing primary, elective unicompartmental knee arthroplasty (UKA) performed using standard manual instrumentation and mechanical cutting guides | |
| Robotic Technique UKA group | This cohort includes patients undergoing primary, elective UKA where the surgeon utilizes robotic-assisted technology for bone resection and component positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon Energy Expenditure (kcal)
The total metabolic energy consumed by the surgeon during the surgical procedure, measured in kilocalories (kcal).
Measured: intraoperative (measured continuously from surgical draping to wound closure)
Secondary outcomes (2)
Surgeon Heart Rate (BPM)
The average and peak heart rate of the surgeon, measured in beats per minute (BPM) to assess cardiovascular stress
Measured: intraoperative. (measured continuously from surgical draping to wound closure)
Minute Ventilation (mL/min)
The volume of gas inhaled or exhaled from the surgeon's lungs per minute, used as an indicator of respiratory effort and physical exertion
Measured: intraoperative. (measured continuously from surgical draping to wound closure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgeon Physiologic StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- ASL Lecce
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jacopo Conteduca, ASL Lecce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495618
- Sponsor's protocol ID
- UKA-STRESS-HEXO-01
- Acronym
- UKA-STRESS
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including surgeon physiologic metrics and patient demographic variables) that underlie the results reported in the final article will be made available to researchers who provide a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeon Physiologic Stress During Unicompartmental Knee Arthroplasty: Manual vs Computer-Assisted Technique
- ClinicalTrials.gov ID
- NCT07495618
- Acronym / sponsor ID
- UKA-STRESS / UKA-STRESS-HEXO-01
- Conditions
- Surgeon Physiologic Stress
- Keywords
- Unicompartmental Knee Arthroplasty, Knee Osteoarthritis, Surgeon Physiologic Demand
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ASL LecceOther government
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Technique UKA group | – | –This cohort consists of patients undergoing primary, elective unicompartmental knee arthroplasty (UKA) performed using standard manual instrumentation and mechanical cutting guides |
| Robotic Technique UKA group | – | –This cohort includes patients undergoing primary, elective UKA where the surgeon utilizes robotic-assisted technology for bone resection and component positioning |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study population consists of adult patients scheduled for elective, primary unicompartmental knee arthroplasty (UKA) at a high-volume orthopedic specialty center. This population includes individuals with symptomatic knee osteoarthritis limited to a single compartment (medial or lateral) who have failed conservative management. The cohort represents a broad range of body mass index (BMI) scores and age groups, reflecting the typical demographic of patients seeking partial knee replacement. Participants are selected based on the surgeon's clinical decision to utilize either a manual technique or a computer-assisted/robotic system, allowing for a real-world observational comparison of surgical physical demand.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Surgeon Heart Rate (BPM)
Time frame: intraoperative. (measured continuously from surgical draping to wound closure)
Minute Ventilation (mL/min)
Time frame: intraoperative. (measured continuously from surgical draping to wound closure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including surgeon physiologic metrics and patient demographic variables) that underlie the results reported in the final article will be made available to researchers who provide a methodologically sound proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgeon Physiologic Stress, run by ASL Lecce at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacopo Conteduca, MD (0039. 3332280645, CONTEDUCA85@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon Energy Expenditure (kcal) (time frame: intraoperative (measured continuously from surgical draping to wound closure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.