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Intraoperative Energy Expenditure During ACL Reconstruction Surgery

27. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

80

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Italien
      • Lecce, Italien
        • Rekruttering
        • Vito Fazzi Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Energy Expenditure
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
minute ventilation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ASL Lecce

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2025

Primær færdiggørelse (Anslået)

30. august 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

27. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HEX-ACL-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med ACL skade

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bangladesh

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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