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Recruiting NCT07683247

Intraoperative Energy Expenditure During ACL Reconstruction Surgery

Observational ACL Injury Meniscal Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: ACL Injury, Meniscal Injuries. Basic parameters: 16 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Total Energy Expenditure [Time frame: During surgery, from skin incision to wound closure]
Secondary outcome measures (3)
  • minute ventilation [Time frame: During surgery, from skin incision to wound closure.]
  • Mean heart rate [Time frame: During surgery, from skin incision to wound closure.]
  • surgical time [Time frame: during surgery, from skin incision to wound closure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Vito Fazzi Hospital — Lecce

Identifiers

NCT: NCT07683247 · HEX-ACL-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗