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

NCT07495618 | Not Yet Recruiting

• 1 other identifier: UKA-STRESS-HEXO-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgeon Physiologic Stress

Keywords

Unicompartmental Knee Arthroplasty; Knee Osteoarthritis; Surgeon Physiologic Demand

Outcome Measures

Primary Outcomes (1)

• Surgeon Energy Expenditure (kcal)

  The total metabolic energy consumed by the surgeon during the surgical procedure, measured in kilocalories (kcal).

  intraoperative (measured continuously from surgical draping to wound closure)

Secondary Outcomes (2)

• Surgeon Heart Rate (BPM)

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

• Minute Ventilation (mL/min)

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

Other Outcomes (1)

• Operative Time (Minutes)

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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ASL Lecce: lead

Study Sites (1)

Kormed Casa Di Cura San Camillo

Forte dei Marmi, LUCCA, 55042, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Jacopo Conteduca, MD

CONTACT

0039. 3332280645; CONTEDUCA85@GMAIL.COM

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• Access Criteria: Data requests should be directed to xxonteduca85@gmail.com. To gain access, data requestors will need to sign a data access agreement.

Locations

IT (1)