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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-95
SponsorASL Lecce

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Manual Technique UKA group
Group B: Robotic Technique UKA group

Trial outcomes

Primary outcomes

1

Surgeon Energy Expenditure (kcal)

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)

Secondary outcomes

1

Surgeon Heart Rate (BPM)

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)
2

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

Time frame
intraoperative. (measured continuously from surgical draping to wound closure)

Other outcomes

1

Operative Time (Minutes)

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.

Time frame
intraoperative. (measured continuously from surgical draping to wound closure)

Sponsors and contacts

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