Surgeon Physiologic Stress During Unicompartmental Knee Arthroplasty: Manual vs Computer-Assisted Technique (UKA-STRESS)

ASL Lecce

Status: Not yet enrolling

Conditions: Surgeon Physiologic Stress

Study type: Observational

Funder types: Other

Identifiers

NCT07495618

UKA-STRESS-HEXO-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

80 participants in 2 patient groups

Manual Technique UKA group

Description:

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

Description:

This cohort includes patients undergoing primary, elective UKA where the surgeon utilizes robotic-assisted technology for bone resection and component positioning