Intraoperative Energy Expenditure During ACL Reconstruction Surgery

June 27, 2026 updated by: Jacopo Conteduca, ASL Lecce

Prospective Assessment of Surgeon Energy Expenditure Using Hexoskin During Anterior Cruciate Ligament Reconstruction: Influence of Anterolateral Ligament Reconstruction and Meniscal Procedures

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Lecce, Italy
        • Recruiting
        • Vito Fazzi Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Energy Expenditure
Time Frame: During surgery, from skin incision to wound closure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
minute ventilation
Time Frame: During surgery, from skin incision to wound closure.
Mean minute ventilation of the operating surgeon measured during the surgical procedure using the Hexoskin wearable device, expressed in liters per minute.
During surgery, from skin incision to wound closure.
Mean heart rate
Time Frame: During surgery, from skin incision to wound closure.
Mean heart rate of the operating surgeon measured during the surgical procedure using the Hexoskin wearable device, expressed in beats per minute.
During surgery, from skin incision to wound closure.
surgical time
Time Frame: during surgery, from skin incision to wound closure
Total surgical time, measured in minutes, from skin incision to wound closure.
during surgery, from skin incision to wound closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASL Lecce

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 27, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 27, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEX-ACL-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected during this study will not be made publicly available because informed consent for data sharing was not obtained and data are subject to institutional privacy and ethical restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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