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Wearable shirt tracks surgeon fatigue during knee surgery

NCT ID NCT07683247

Knowledge-focused Sponsor: ASL Lecce Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study uses a special wearable shirt to measure how much energy surgeons burn during ACL reconstruction surgery. Researchers want to see if adding extra procedures, like repairing other knee ligaments or treating meniscus tears, increases the surgeon's physical workload. The goal is to understand which parts of the surgery are most tiring for the surgeon.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify which surgical steps are most physically demanding, potentially guiding training or ergonomic improvements for surgeons.
What could go wrong
This is an observational study with a small sample size, so results may not apply broadly. The wearable device may not capture all aspects of workload.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

16 to 49 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acl injury Meniscal injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vito Fazzi Hospital

    RECRUITING

    Lecce, Italy

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