[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631049":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":26,"overallOfficials":26,"centralContacts":38,"locations":44,"responsibleParty":66,"collaborators":26,"id":70,"slug":26,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":82,"studyType":83,"phases":26,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":91,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"ASL Lecce","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"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)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Surgeon Heart Rate (BPM)","The average and peak heart rate of the surgeon, measured in beats per minute (BPM) to assess cardiovascular stress","intraoperative. (measured continuously from surgical draping to wound closure)",{"measure":19,"description":20,"timeFrame":17},"Minute Ventilation (mL\u002Fmin)","The volume of gas inhaled or exhaled from the surgeon's lungs per minute, used as an indicator of respiratory effort and physical exertion",[22],{"measure":23,"description":24,"timeFrame":17},"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.",{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":27,"timePerspective":28,"maskingInfo":26},null,"COHORT","PROSPECTIVE","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.\n\nRecent 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.\n\nThe 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).\n\nPatient 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.\n\nThe 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.","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\u002Frobotic system, allowing for a real-world observational comparison of surgical physical demand.",[32,35],{"label":33,"type":26,"description":34,"interventionNames":26},"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",{"label":36,"type":26,"description":37,"interventionNames":26},"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",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Jacopo Conteduca, MD","CONTACT","0039. 3332280645","CONTEDUCA85@GMAIL.COM",[45],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Kormed Casa Di Cura San Camillo","Forte dei Marmi","LUCCA","55042","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],10.17478,43.96388,{"lat":56,"lon":55},[59,63],{"name":60,"role":41,"phone":61,"phoneExt":26,"email":62},"GIOVANNI PELLICCIA, MD","0039 3480364112","juanpellix@gmail.com",{"name":64,"role":65,"phone":26,"phoneExt":26,"email":26},"Giovanni Pelliccia, MD","SUB_INVESTIGATOR",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jacopo Conteduca","MD","100631049",false,"NCT07495618","Surgeon Physiologic Stress During Unicompartmental Knee Arthroplasty: Manual vs Computer-Assisted Technique","UKA-STRESS","Inclusion Criteria:\n\n* primary, elective unicompartmental knee arthroplasty (UKA).\n* Clinical and radiographic evidence of symptomatic unicompartmental knee osteoarthritis.\n* Candidates for either manual or computer-assisted\u002Frobotic cemented UKA.\n* Procedures performed by fellowship-trained arthroplasty surgeons to ensure technical consistency.\n* Patients willing and able to provide informed consent for the collection of perioperative data.\n\nExclusion Criteria\n\n* Revision Surgery: Patients undergoing revision knee arthroplasty (as the study focuses on primary cases).\n* Complex Scars: Presence of significant prior knee surgery or hardware that may abnormally increase surgical difficulty.\n* Inflammatory Arthritis: Patients with inflammatory conditions like rheumatoid arthritis (optional, depending on your focus).\n* Non-elective or trauma-related knee procedures.\n* Surgeon Limitation: Any physical condition of the participating surgeon that prevents the use of the wearable monitoring garment.","ALL","18 Years","95 Years",{"count":80,"type":81},80,"ESTIMATED","3 Months","OBSERVATIONAL","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.",[86],"Surgeon Physiologic Stress",[88,89,90],"Unicompartmental Knee Arthroplasty","Knee Osteoarthritis","Surgeon Physiologic Demand","NOT_YET_RECRUITING","2026-03-24",{"date":94,"type":95},"2026-03-27","ACTUAL",{"date":97,"type":81},"2026-03-20",{"date":99,"type":81},"2027-04",{"name":5,"class":6},1]