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Recruiting NCT07683247

Intraoperative Energy Expenditure During ACL Reconstruction Surgery

Conditions: ACL Injury, Meniscal Injuries

Sex: All
Ages: 16 Years – 49 Years
Healthy volunteers: No
Enrollment: 80
Sponsor: ASL Lecce

Location: Vito Fazzi Hospital Lecce

Summary

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

Inclusion Criteria: * 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 Exclusion Criteria: * Revision ACL reconstruction * Multiligament knee reconstruction * Bilateral knee surgery * Concomitant procedures other than ACL reconstruction, ALL reconstruction, meniscal repair, or partial meniscectomy * Incomplete intraoperative Hexoskin recording * Conversion or interruption of the planned surgical procedure

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07683247). StuddyBuddy aggregates publicly available trial information.