NCT07683247 Intraoperative Energy Expenditure During ACL Reconstruction Surgery
| NCT ID | NCT07683247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ASL Lecce |
| Condition | ACL Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-02-01 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07683247 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 49 Years, studying ACL Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07683247 currently recruiting?
Yes, NCT07683247 is actively recruiting participants. Contact the research team at conteduca85@gmail.com for enrollment information.
Where is the NCT07683247 trial being conducted?
This trial is being conducted at Lecce, Italy.
Who is sponsoring the NCT07683247 clinical trial?
NCT07683247 is sponsored by ASL Lecce. The trial plans to enroll 80 participants.