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NCT Number: NCT07683247

Intraoperative Energy Expenditure During ACL Reconstruction Surgery

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.

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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Meniscal Injuries Wounds and Injuries

Age range

16 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. surgical time

    Time frame: during surgery, from skin incision to wound closure

    Total surgical time, measured in minutes, from skin incision to wound closure.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacopo Conteduca, md

CONTACT

[email protected]

0039 3332280645

Sponsors and collaborators

Lead sponsor

ASL Lecce

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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