Intraoperative Energy Expenditure During ACL Reconstruction Surgery

NCT07683247 | Recruiting

• 1 other identifier: HEX-ACL-2026-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Injury; Meniscal Injuries

Keywords

Anterior cruciate ligament; Hexoskin; ACL reconstruction; Wearable monitoring; Knee surgery

Outcome Measures

Primary Outcomes (1)

• Total Energy Expenditure

  Total intraoperative energy expenditure of the operating surgeon measured using the Hexoskin wearable device, expressed in kilocalories.

  During surgery, from skin incision to wound closure

Secondary Outcomes (3)

• minute ventilation

  During surgery, from skin incision to wound closure.

• Mean heart rate

  During surgery, from skin incision to wound closure.

• surgical time

  during surgery, from skin incision to wound closure

Study Arms (4)

Isolated ACL Reconstruction

Patients undergoing primary anterior cruciate ligament (ACL) reconstruction without anterolateral ligament (ALL) reconstruction and without meniscal treatment.

ACL Reconstruction With ALL Reconstruction

Patients undergoing primary ACL reconstruction combined with anterolateral ligament (ALL) reconstruction, without associated meniscal treatment.

ACL Reconstruction With Meniscal Treatment

Patients undergoing primary ACL reconstruction with associated meniscal repair or partial meniscectomy, without ALL reconstruction.

ACL Reconstruction With ALL Reconstruction and Meniscal Treatment

Patients undergoing primary ACL reconstruction combined with ALL reconstruction and associated meniscal repair or partial meniscectomy.

Eligibility Criteria

• Age: 16 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ASL Lecce: lead

Study Sites (1)

Vito Fazzi Hospital

Lecce, Italy

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Jacopo Conteduca, md

CONTACT

0039 3332280645; conteduca85@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 6, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)