Intraoperative Energy Expenditure During ACL Reconstruction Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-49
SponsorASL Lecce
About this trial
This prospective observational study evaluates the intraoperative energy expenditure of the surgeon during anterior cruciate ligament reconstruction procedures. Energy expenditure and physiological workload will be measured using a wearable Hexoskin shirt during surgery.
The study will compare surgical procedures involving isolated anterior cruciate ligament reconstruction, anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction, and procedures requiring additional meniscal treatment. The aim is to determine whether anterolateral ligament reconstruction meaningfully increases surgeon workload and whether meniscal procedures are associated with higher intraoperative energy expenditure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing primary anterior cruciate ligament reconstruction
Unilateral ACL rupture confirmed by clinical examination and MRI
Surgery performed by the participating surgeon wearing the Hexoskin device
Ability to provide written informed consent
Disqualifiers
Revision ACL reconstruction
Multiligament knee reconstruction
Bilateral knee surgery
Concomitant procedures other than ACL reconstruction, ALL reconstruction, meniscal repair, or partial meniscectomy
Trial population
he study population will include patients undergoing primary anterior cruciate ligament (ACL) reconstruction at the participating center. Patients may undergo isolated ACL reconstruction, ACL reconstruction combined with anterolateral ligament (ALL) reconstruction, ACL reconstruction with associated meniscal treatment, or ACL reconstruction combined with both ALL reconstruction and meniscal treatment. During each surgical procedure, the operating surgeon will wear a Hexoskin device to record intraoperative physiological parameters and estimate energy expenditure. Surgical indication and associated procedures will be determined according to standard clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 4 trial groupsGroup A: Isolated ACL Reconstruction
Group B: ACL Reconstruction With ALL Reconstruction
Group C: ACL Reconstruction With Meniscal Treatment
Group D: ACL Reconstruction With ALL Reconstruction and Meniscal Treatment
Trial outcomes
Primary outcomes
1
Total Energy Expenditure
Total intraoperative energy expenditure of the operating surgeon measured using the Hexoskin wearable device, expressed in kilocalories.
Time frame
During surgery, from skin incision to wound closureSecondary outcomes
1
minute ventilation
Mean minute ventilation of the operating surgeon measured during the surgical procedure using the Hexoskin wearable device, expressed in liters per minute.
Time frame
During surgery, from skin incision to wound closure.2
Mean heart rate
Mean heart rate of the operating surgeon measured during the surgical procedure using the Hexoskin wearable device, expressed in beats per minute.
Time frame
During surgery, from skin incision to wound closure.3
surgical time
Total surgical time, measured in minutes, from skin incision to wound closure.
Time frame
during surgery, from skin incision to wound closure Source ClinicalTrials.gov