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Active, not recruiting

NCT Number: NCT07589582

Active Noise-Cancelling Headphones With Closed-Loop Communication During Arthroscopic ACL Reconstruction

Operating room noise may interfere with communication, concentration, and surgical workflow. Active noise-cancelling (ANC) headphones can reduce background auditory distractions; however, their potential benefit during surgery may depend on maintaining effective communication among surgical team members. This prospective randomized controlled trial evaluates the effect of ANC headphones integrated with a closed-loop communication system on operative efficiency and intraoperative workflow during arthroscopic anterior cruciate ligament (ACL) reconstruction. Participants undergoing primary arthroscopic ACL reconstruction are randomized to either an ANC group or a control group. In the ANC group, the surgeon, first assistant, and scrub nurse use ANC headphones connected through a closed-loop communication system during surgery. The control group undergoes surgery under standard operating room conditions. The primary outcome is operative time from skin incision to skin closure. Secondary outcomes include command acknowledgment time, instrument handover time, and repeated verbal requests assessed using objective video-based workflow analysis.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 340000, Turkey (Türkiye)

About this study

Operating room noise represents a potential source of distraction and may interfere with effective communication, concentration, coordination, and surgical workflow. Active noise-cancelling headphones can reduce perceived background auditory stimuli; however, conventional noise-cancelling devices may also interfere with communication when used without a dedicated communication system.

This prospective, single-center, randomized controlled trial evaluates whether active noise-cancelling headphones integrated with a closed-loop communication system improve operative efficiency and intraoperative workflow during arthroscopic anterior cruciate ligament reconstruction.

Patients undergoing primary arthroscopic ACL reconstruction for isolated ACL rupture are randomized in a 1:1 ratio to an intervention group or a control group.

In the intervention group, the surgeon, first assistant, and scrub nurse use active noise-cancelling headphones connected through a closed-loop communication system throughout the surgical procedure. This system is designed to reduce perceived background auditory distractions while maintaining continuous verbal communication among the core surgical team. The anesthesia team does not use headphones and maintains awareness of monitor alarms, ventilator alarms, and operating room announcements. When required, communication between the anesthesia and surgical teams occurs using standard verbal communication.

In the control group, arthroscopic ACL reconstruction is performed under standard operating room conditions without active noise-cancelling headphones or an additional closed-loop communication system.

All procedures are performed using a standardized single-bundle hamstring autograft ACL reconstruction technique, standardized instrumentation, fixation systems, arthroscopic equipment, and operating room setup.

The primary objective is to evaluate the effect of ANC-assisted closed-loop communication on operative time. Secondary objectives include assessment of objective communication and workflow parameters, including command acknowledgment time, instrument handover time, and repeated verbal requests.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 50 years
  • Primary arthroscopic anterior cruciate ligament reconstruction
  • Isolated ACL rupture confirmed by clinical examination and magnetic resonance imaging
  • Ability to provide written informed consent

Exclusion criteria

  • Concomitant meniscal injury
  • Multiligament knee injury
  • Previous ipsilateral knee surgery
  • Concomitant fracture
  • Concomitant cartilage restoration procedure
  • Concomitant osteotomy
  • Revision ACL reconstruction
  • American Society of Anesthesiologists physical status greater than III

Treatment and study plan

Active Noise-Cancelling Headphones With Closed-Loop Communication

Device

Active noise-cancelling headphones connected through a closed-loop communication system are used by the surgeon, first assistant, and scrub nurse throughout arthroscopic ACL reconstruction. The system is intended to reduce perceived background auditory distractions while maintaining continuous verbal communication among the core surgical team.

Standard Operating Room Communication

Other

The surgical team performs arthroscopic ACL reconstruction under routine operating room conditions and communicates using standard verbal communication without active noise-cancelling headphones or a dedicated closed-loop communication system.

Primary outcomes

  1. Operation Time

    Time frame: Intraoperative, from skin incision to completion ofskin closure

    Operative time is defined as the elapsed time from skin incision to completion of skin closure and is measured in minutes.

Secondary outcomes

  1. Command Acknowledgment Time

    Time frame: Intraoperative, during predefined standardized instrument-request events

    Command acknowledgment time is defined as the interval between the surgeon's verbal request and the first verbal acknowledgment by the first assistant or scrub nurse. Measurements are obtained from video recordings of predefined standardized intraoperative communication events.

  2. Instrument Handover Time

    Time frame: Intraoperative, during predefined standardized instrument-request events

    Instrument handover time is defined as the interval between the surgeon's verbal request for an instrument and physical delivery of the requested instrument. Measurements are obtained from video recordings of predefined standardized intraoperative instrument-request events.

  3. Repeated Verbal Requests

    Time frame: Intraoperative, during the surgical procedure

    A repeated verbal request is defined as any verbal request repeated because of an absent, delayed, or inadequate response. The number of repeated requests is determined using video recordings of predefined standardized intraoperative communication events.

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

Effect of Active Noise-Cancelling Headphones With Closed-Loop Communication on Operative Efficiency During Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

Acronym: ANC-ACL-2026

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
Sep 10, 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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