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Clinical Trials in Turkey / NCT07589582
Active, not recruiting Not applicable

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

NCT07589582 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-04-25
Last updated
2026-09-10

Condition(s) studied

Anterior Cruciate Ligament RuptureAnterior Cruciate Ligament (ACL) TearAnterior Cruciate Ligament Injury

Investigational drug(s) / intervention(s)

Active Noise-Cancelling Headphones With Closed-Loop CommunicationStandard Operating Room Communication

Active Noise-Cancelling Headphones With Closed-Loop Communication: 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: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital Istanbul Turkey (Türkiye)

More Fatih Sultan Mehmet Training and Research Hospital trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07589582 on ClinicalTrials.gov ↗ ← All trials in Turkey