Anterior Cruciate Ligament RuptureANC-ACL-2026NCT07589582
Active Noise-Cancelling Headphones With Closed-Loop Communication During Arthroscopic ACL Reconstruction
A study testing Active Noise-Cancelling Headphones With Closed-Loop Communication and Standard Operating Room Communication in people with Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament (ACL) Tear, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament (ACL) Tear, Anterior Cruciate Ligament Injury
- What is being tested?
- Active Noise-Cancelling Headphones With Closed-Loop Communication and Standard Operating Room Communication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 340000
About this study
Official title: Effect of Active Noise-Cancelling Headphones With Closed-Loop Communication on Operative Efficiency During Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament (ACL) Tear, Anterior Cruciate Ligament Injury
- Being tested
- Active Noise-Cancelling Headphones With Closed-Loop Communication, Standard Operating Room Communication
- Keywords
- Anterior Cruciate Ligament Reconstruction, ACL Reconstruction, Active Noise Cancellation, Noise-Cancelling Headphones, Operating Room Noise, Operating Room Communication, Closed-Loop Communication, Surgical Workflow, Operative Efficiency, Arthroscopy
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Lacerations, Teach-Back Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Noise-Cancelling Headphones With Closed-Loop CommunicationDevice
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 CommunicationOther
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 group | Role | What they receive |
|---|---|---|
| ANC With Closed-Loop Communication | Experimental | Participants undergo arthroscopic ACL reconstruction while the surgeon, first assistant, and scrub nurse use active noise-cancelling headphones connected through a closed-loop communication system. The system allows continuous verbal communication among the core surgical team while reducing perceived background auditory distractions. Receives: Device: Active Noise-Cancelling Headphones With Closed-Loop Communication |
| Standard Operating Room Communication | Active comparator | Participants undergo the same standardized arthroscopic anterior cruciate ligament reconstruction under routine operating room conditions. The surgeon, first assistant, and scrub nurse communicate using standard verbal communication without active noise-cancelling headphones or a dedicated closed-loop communication system. Receives: Other: Standard Operating Room Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation Time
Operative time is defined as the elapsed time from skin incision to completion of skin closure and is measured in minutes.
Measured: Intraoperative, from skin incision to completion ofskin closure
Secondary outcomes (3)
Command Acknowledgment Time
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.
Measured: Intraoperative, during predefined standardized instrument-request events
Instrument Handover Time
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.
Measured: Intraoperative, during predefined standardized instrument-request events
Repeated Verbal Requests
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.
Measured: Intraoperative, during the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start25 Apr 2026
- Primary completion5 Oct 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to either active noise-cancelling headphones with closed-loop communication or standard operating room conditions.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Sivritaş, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- ONUR GULTEKIN, MD, Principal investigator, FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589582
- Sponsor's protocol ID
- ANC-ACL-26
- Acronym
- ANC-ACL-2026
- Status last verified
- Sep 2026
- First submitted
- 11 May 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be publicly shared.
Publications
Oomens P, Fu VX, Kleinrensink VEE, Kleinrensink GJ, Jeekel J. The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study. World J Surg. 2020 Aug;44(8):2614-2619. doi: 10.1007/s00268-020-05523-0.
PubMed 32333159Fancourt D, Burton TM, Williamon A. The razor's edge: Australian rock music impairs men's performance when pretending to be a surgeon. Med J Aust. 2016 Dec 12;205(11):515-518. doi: 10.5694/mja16.01045.
PubMed 27927145Wu T, Qi H, Hui K, Hu Y, Xu M, Zhou J, Duan M. Effect of noise isolation with noise-cancelling earmuffs during laparoscopic surgery on acute postoperative pain: a clinical randomised controlled trial. BMC Anesthesiol. 2025 Oct 14;25(1):498. doi: 10.1186/s12871-025-03369-4.
PubMed 41087929
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Active Noise-Cancelling Headphones With Closed-Loop Communication on Operative Efficiency During Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07589582
- Acronym / sponsor ID
- ANC-ACL-2026 / ANC-ACL-26
- Conditions
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament (ACL) Tear, Anterior Cruciate Ligament Injury
- Keywords
- Anterior Cruciate Ligament Reconstruction, ACL Reconstruction, Active Noise Cancellation, Noise-Cancelling Headphones, Operating Room Noise, Operating Room Communication, Closed-Loop Communication, Surgical Workflow
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- 5 Oct 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to either active noise-cancelling headphones with closed-loop communication or standard operating room conditions.
| Arm | Type | Receives |
|---|---|---|
| ANC With Closed-Loop Communication | Experimental | Device: Active Noise-Cancelling Headphones With Closed-Loop CommunicationParticipants undergo arthroscopic ACL reconstruction while the surgeon, first assistant, and scrub nurse use active noise-cancelling headphones connected through a closed-loop communication system. The system allows continuous verbal communication among the core surgical team while reducing perceived background auditory distractions. |
| Standard Operating Room Communication | Active comparator | Other: Standard Operating Room CommunicationParticipants undergo the same standardized arthroscopic anterior cruciate ligament reconstruction under routine operating room conditions. The surgeon, first assistant, and scrub nurse communicate using standard verbal communication without active noise-cancelling headphones or a dedicated closed-loop communication system. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Concomitant meniscal injury
- Multiligament knee injury
- Previous ipsilateral knee surgery
- Concomitant fracture
- Concomitant cartilage restoration procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Noise-Cancelling Headphones With Closed-Loop CommunicationActive 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. | Device | ANC With Closed-Loop Communication |
| Standard Operating Room CommunicationThe 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. | Other | Standard Operating Room Communication |
Primary outcome
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.
3 secondary outcomes
Command Acknowledgment Time
Time frame: Intraoperative, during predefined standardized instrument-request events
Instrument Handover Time
Time frame: Intraoperative, during predefined standardized instrument-request events
Repeated Verbal Requests
Time frame: Intraoperative, during the surgical procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 32333159Oomens P, Fu VX, Kleinrensink VEE, Kleinrensink GJ, Jeekel J. The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study. World J Surg. 2020 Aug;44(8):2614-2619. doi: 10.1007/s00268-020-05523-0.
- Background: PubMed 27927145Fancourt D, Burton TM, Williamon A. The razor's edge: Australian rock music impairs men's performance when pretending to be a surgeon. Med J Aust. 2016 Dec 12;205(11):515-518. doi: 10.5694/mja16.01045.
- Background: PubMed 41087929Wu T, Qi H, Hui K, Hu Y, Xu M, Zhou J, Duan M. Effect of noise isolation with noise-cancelling earmuffs during laparoscopic surgery on acute postoperative pain: a clinical randomised controlled trial. BMC Anesthesiol. 2025 Oct 14;25(1):498. doi: 10.1186/s12871-025-03369-4.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be publicly shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ONUR GULTEKIN, MD principal investigator
FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Noise-Cancelling Headphones With Closed-Loop Communication and Standard Operating Room Communication in people with Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament (ACL) Tear, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation Time (time frame: Intraoperative, from skin incision to completion ofskin closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07589582, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.