Anterior Cruciate Ligament InjuriesVIDEO-ACLRNCT07540715
Effect of Intraoperative Live Video Viewing on Kinesiophobia After ACL Reconstruction
A study testing Intraoperative Live Video Viewing and Standard ACL Reconstruction in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Reconstruction, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this randomized controlled trial is to investigate whether intraoperative live arthroscopic video viewing improves postoperative psychological and functional outcomes in patients undergoing primary anterior cruciate ligament (ACL) reconstruction under spinal anesthesia Participants are randomly assigned… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Kinesiophobia
- What is being tested?
- Intraoperative Live Video Viewing and Standard ACL Reconstruction
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 years and older.
- Diagnosis of isolated anterior cruciate ligament (ACL) rupture.
- Scheduled to undergo primary arthroscopic ACL reconstruction under spinal anesthesia.
Who cannot join
- Concomitant knee injuries requiring additional surgical procedures that substantially alter early postoperative weight-bearing and rehabilitation (e.g., meniscal repair or microfracture)
- Multiligament injury or posterior cruciate ligament (PCL) injury.
- Advanced chondral damage, rheumatologic disease, bleeding diathesis, or active local/systemic infection
- Psychiatric disorders requiring active treatment
- Inability to remain conscious, cooperative, and communicative throughout the procedure (e.g., developing deep sedation with a Ramsay score >2 or requiring conversion to general anesthesia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Intraoperative Live Arthroscopic Video Viewing on Kinesiophobia and Functional Outcomes After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
The purpose of this randomized controlled trial is to investigate whether intraoperative live arthroscopic video viewing improves postoperative psychological and functional outcomes in patients undergoing primary anterior cruciate ligament (ACL) reconstruction under spinal anesthesia Participants are randomly assigned to either a video-viewing group, where they watch their surgery in real-time, or a control group receiving standard care without visual feedback The primary objective is to determine whether this patient-specific visual biofeedback reduces postoperative kinesiophobia at 24 weeks.
Secondary objectives aim to evaluate the intervention's effects on state anxiety, illness perception, postoperative pain, and patient-reported functional recovery, including IKDC, Lysholm, and SF-36 scores
.
Read the detailed description
Return to preinjury competitive sports following anterior cruciate ligament reconstruction (ACLR) remains suboptimal despite successful surgical and mechanical restoration Psychological factors, particularly kinesiophobia (fear of movement) and state anxiety, act as significant barriers to functional recovery, rehabilitation adherence, and return to sport Although the biopsychosocial model is increasingly recognized in orthopedic rehabilitation, patient-specific perioperative interventions designed to mitigate these psychological barriers remain limited This prospective, parallel-group, assessor-blinded, randomized controlled trial aims to investigate whether active patient engagement through intraoperative live arthroscopic video viewing can improve postoperative psychological and functional outcomes Eligible adult patients scheduled for primary ACLR under spinal anesthesia are randomized in a 1:1 ratio into an intervention (video-viewing) group or a control group All surgical procedures are performed by a single experienced orthopedic surgeon using an anatomic single-bundle reconstruction technique with a hamstring tendon autograft In the intervention group, the arthroscopic monitor is positioned within the patient's direct visual field.
While under spinal anesthesia, patients watch the procedure live During the operation, the surgeon provides a standardized, step-by-step verbal explanation of the normal intra-articular structures, the torn ACL, the reconstruction steps, and the final graft appearance In the control group, patients receive standard surgical care and routine perioperative communication under the same anesthetic conditions but are not allowed to view the arthroscopic monitor.
To ensure the intervention is adequately delivered, patients must remain conscious and cooperative throughout the surgery; those developing deep sedation (Ramsay Sedation Scale score >2) or requiring conversion to general anesthesia are excluded Following surgery, both groups undergo an identical, standardized rehabilitation protocol This protocol includes early mobilization with an angle-adjustable brace, immediate weight-bearing as tolerated, deep vein thrombosis prophylaxis, and a progressive home exercise program focusing on quadriceps strengthening Data collection is performed preoperatively and at 4 and 24 weeks postoperatively by independent clinical specialists who are completely blinded to group allocation An independent psychiatrist evaluates psychological outcomes, including the Tampa Scale of Kinesiophobia (TSK-11, primary outcome), the State-Trait Anxiety Inventory (STAI), and the Brief Illness Perception Questionnaire (B-IPQ) Concurrently, an independent Physical Medicine and Rehabilitation specialist assesses functional outcomes and pain using the International Knee Documentation Committee (IKDC) Subjective Knee Form, the Lysholm Knee Score, the Short Form-36 (SF-36) Physical Function subscale, and a Visual Analog Scale (VAS) for pain The primary objective is to determine if real-time visualization of the reconstructed knee anatomy reduces postoperative kinesiophobia at 24 weeks compared to standard care
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Kinesiophobia, Anxiety
- Being tested
- Intraoperative Live Video Viewing, Standard ACL Reconstruction
- Keywords
- Anterior Cruciate Ligament Reconstruction, Kinesiophobia, Intraoperative Video, Visual Biofeedback, Anxiety, Functional Recovery
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Kinesiophobia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Live Video ViewingBehavioural
Also called Visual Biofeedback
A patient-centered cognitive intervention providing real-time visual feedback of the reconstructed knee anatomy to mitigate psychological barriers such as kinesiophobia and
Standard ACL ReconstructionProcedure or surgery
Also called Standard Surgical Care
Routine primary arthroscopic anterior cruciate ligament reconstruction without targeted visual or structured cognitive interventions.
| Study group | Role | What they receive |
|---|---|---|
| Video Viewing Group | Experimental | Participants view the arthroscopic procedure live on the operating room monitor while under spinal anesthesia
* The monitor is positioned within the patient's direct visual field
* During the procedure, the operating surgeon provides standardized step-by-step verbal explanations describing the normal intra-articular structures, the torn ACL, the major steps of reconstruction, and the final appearance of the graft
* All other perioperative management, standard surgical care, and postoperative rehabilitation are identical to the control group Receives: Behavioral: Intraoperative Live Video Viewing |
| Control Group | Active comparator | Participants undergo the same standardized arthroscopic anterior cruciate ligament reconstruction procedure under the same anesthetic and perioperative conditions as the experimental group, but are not allowed to view the arthroscopic monitor
. They receive routine perioperative communication and standard surgical care, but no structured intraoperative explanation of arthroscopic findings or reconstruction steps is provided Receives: Procedure: Standard ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Scale of Kinesiophobia (TSK-11) Score
Kinesiophobia (fear of movement or reinjury) is assessed using the 11-item Tampa Scale of Kinesiophobia. The total score ranges from 11 to 44, with higher scores indicating a greater degree of kinesiophobia and fear of movement.
Measured: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
Secondary outcomes (6)
State-Trait Anxiety Inventory (STAI) Score
Postoperative state anxiety is measured using the STAI. Higher scores indicate greater levels of anxiety.
Measured: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
Brief Illness Perception Questionnaire (B-IPQ) Score
The B-IPQ is used to assess the cognitive and emotional representations of the patient's illness/injury. Higher scores indicate more threatening views and a more negative perception of the illness.
Measured: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
Visual Analog Scale (VAS) for Pain
Postoperative pain intensity is assessed using a Visual Analog Scale. Scores range from 0 to 10, with 0 representing "no pain" and 10 representing "worst possible pain." Higher scores indicate greater pain severity.
Measured: 4 weeks and 24 weeks postoperatively
International Knee Documentation Committee (IKDC) Subjective Knee Form Score
The IKDC Subjective Knee Form is used to evaluate patient-reported knee symptoms, function, and sports activity. Scores are transformed to a scale of 0 to 100, with higher scores indicating fewer symptoms, better knee function, and higher levels of sports activity.
Measured: 4 weeks and 24 weeks postoperatively
Lysholm Knee Score
The Lysholm Knee Score is a condition-specific outcome measure that evaluates knee function and symptoms, such as limping, locking, pain, and instability. The total score ranges from 0 to 100, with higher scores representing better knee function and fewer symptoms.
Measured: 4 weeks and 24 weeks postoperatively
Short Form-36 (SF-36) Physical Function Subscale Score
Patient-reported physical functioning is evaluated using the Physical Function subscale of the SF-36 health survey. Scores are transformed to range from 0 to 100, with higher scores indicating better physical functioning and less limitation.
Measured: 4 weeks and 24 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Jan 2023
- Primary completion20 Apr 2025
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the intervention group (intraoperative video viewing) or the control group (standard care) to proceed in parallel for the 24-week duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oğuzhan PEKİNCE, Konya City Hospital
- Investigators
- Oğuzhan Pekince, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540715
- Sponsor's protocol ID
- NEU-ORTHO-ACL-2022
- Acronym
- VIDEO-ACLR
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly in order to protect patient privacy and confidentiality. However, aggregate data will be available through publication.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Live Arthroscopic Video Viewing on Kinesiophobia and Functional Outcomes After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07540715
- Acronym / sponsor ID
- VIDEO-ACLR / NEU-ORTHO-ACL-2022
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Kinesiophobia, Anxiety
- Keywords
- Anterior Cruciate Ligament Reconstruction, Kinesiophobia, Intraoperative Video, Visual Biofeedback, Anxiety, Functional Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 20 Apr 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.
The purpose of this randomized controlled trial is to investigate whether intraoperative live arthroscopic video viewing improves postoperative psychological and functional outcomes in patients undergoing primary anterior cruciate ligament (ACL) reconstruction under spinal anesthesia Participants are randomly assigned to either a video-viewing group, where they watch their surgery in real-time, or a control group receiving standard care without visual feedback The primary objective is to determine whether this patient-specific visual biofeedback reduces postoperative kinesiophobia at 24 weeks.
Secondary objectives aim to evaluate the intervention's effects on state anxiety, illness perception, postoperative pain, and patient-reported functional recovery, including IKDC, Lysholm, and SF-36 scores
.
Detailed description
Return to preinjury competitive sports following anterior cruciate ligament reconstruction (ACLR) remains suboptimal despite successful surgical and mechanical restoration Psychological factors, particularly kinesiophobia (fear of movement) and state anxiety, act as significant barriers to functional recovery, rehabilitation adherence, and return to sport Although the biopsychosocial model is increasingly recognized in orthopedic rehabilitation, patient-specific perioperative interventions designed to mitigate these psychological barriers remain limited This prospective, parallel-group, assessor-blinded, randomized controlled trial aims to investigate whether active patient engagement through intraoperative live arthroscopic video viewing can improve postoperative psychological and functional outcomes Eligible adult patients scheduled for primary ACLR under spinal anesthesia are randomized in a 1:1 ratio into an intervention (video-viewing) group or a control group All surgical procedures are performed by a single experienced orthopedic surgeon using an anatomic single-bundle reconstruction technique with a hamstring tendon autograft In the intervention group, the arthroscopic monitor is positioned within the patient's direct visual field.
While under spinal anesthesia, patients watch the procedure live During the operation, the surgeon provides a standardized, step-by-step verbal explanation of the normal intra-articular structures, the torn ACL, the reconstruction steps, and the final graft appearance In the control group, patients receive standard surgical care and routine perioperative communication under the same anesthetic conditions but are not allowed to view the arthroscopic monitor.
To ensure the intervention is adequately delivered, patients must remain conscious and cooperative throughout the surgery; those developing deep sedation (Ramsay Sedation Scale score >2) or requiring conversion to general anesthesia are excluded Following surgery, both groups undergo an identical, standardized rehabilitation protocol This protocol includes early mobilization with an angle-adjustable brace, immediate weight-bearing as tolerated, deep vein thrombosis prophylaxis, and a progressive home exercise program focusing on quadriceps strengthening Data collection is performed preoperatively and at 4 and 24 weeks postoperatively by independent clinical specialists who are completely blinded to group allocation An independent psychiatrist evaluates psychological outcomes, including the Tampa Scale of Kinesiophobia (TSK-11, primary outcome), the State-Trait Anxiety Inventory (STAI), and the Brief Illness Perception Questionnaire (B-IPQ) Concurrently, an independent Physical Medicine and Rehabilitation specialist assesses functional outcomes and pain using the International Knee Documentation Committee (IKDC) Subjective Knee Form, the Lysholm Knee Score, the Short Form-36 (SF-36) Physical Function subscale, and a Visual Analog Scale (VAS) for pain The primary objective is to determine if real-time visualization of the reconstructed knee anatomy reduces postoperative kinesiophobia at 24 weeks compared to standard care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the intervention group (intraoperative video viewing) or the control group (standard care) to proceed in parallel for the 24-week duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Video Viewing Group | Experimental | Behavioral: Intraoperative Live Video ViewingParticipants view the arthroscopic procedure live on the operating room monitor while under spinal anesthesia * The monitor is positioned within the patient's direct visual field * During the procedure, the operating surgeon provides standardized step-by-step verbal explanations describing the normal intra-articular structures, the torn ACL, the major steps of reconstruction, and the final appearance of the graft * All other perioperative management, standard surgical care, and postoperative rehabilitation are identical to the control group |
| Control Group | Active comparator | Procedure: Standard ACL ReconstructionParticipants undergo the same standardized arthroscopic anterior cruciate ligament reconstruction procedure under the same anesthetic and perioperative conditions as the experimental group, but are not allowed to view the arthroscopic monitor . They receive routine perioperative communication and standard surgical care, but no structured intraoperative explanation of arthroscopic findings or reconstruction steps is provided |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 years and older.
- Diagnosis of isolated anterior cruciate ligament (ACL) rupture.
- Scheduled to undergo primary arthroscopic ACL reconstruction under spinal anesthesia.
Key exclusion criteria (5 listed)
- Concomitant knee injuries requiring additional surgical procedures that substantially alter early postoperative weight-bearing and rehabilitation (e.g., meniscal repair or microfracture)
- Multiligament injury or posterior cruciate ligament (PCL) injury.
- Advanced chondral damage, rheumatologic disease, bleeding diathesis, or active local/systemic infection
- Psychiatric disorders requiring active treatment
- Inability to remain conscious, cooperative, and communicative throughout the procedure (e.g., developing deep sedation with a Ramsay score >2 or requiring conversion to general anesthesia)
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 |
|---|---|---|
| Intraoperative Live Video ViewingAlso: Visual BiofeedbackA patient-centered cognitive intervention providing real-time visual feedback of the reconstructed knee anatomy to mitigate psychological barriers such as kinesiophobia and | Behavioural | Video Viewing Group |
| Standard ACL ReconstructionAlso: Standard Surgical CareRoutine primary arthroscopic anterior cruciate ligament reconstruction without targeted visual or structured cognitive interventions. | Procedure or surgery | Control Group |
Primary outcome
Tampa Scale of Kinesiophobia (TSK-11) Score
Time frame: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
Kinesiophobia (fear of movement or reinjury) is assessed using the 11-item Tampa Scale of Kinesiophobia. The total score ranges from 11 to 44, with higher scores indicating a greater degree of kinesiophobia and fear of movement.
6 secondary outcomes
State-Trait Anxiety Inventory (STAI) Score
Time frame: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
Brief Illness Perception Questionnaire (B-IPQ) Score
Time frame: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
Visual Analog Scale (VAS) for Pain
Time frame: 4 weeks and 24 weeks postoperatively
International Knee Documentation Committee (IKDC) Subjective Knee Form Score
Time frame: 4 weeks and 24 weeks postoperatively
Lysholm Knee Score
Time frame: 4 weeks and 24 weeks postoperatively
Short Form-36 (SF-36) Physical Function Subscale Score
Time frame: 4 weeks and 24 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly in order to protect patient privacy and confidentiality. However, aggregate data will be available through publication.
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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.
Oğuzhan Pekince, MD principal investigator
Konya City 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 Intraoperative Live Video Viewing and Standard ACL Reconstruction in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Reconstruction, run by Konya City 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 20 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tampa Scale of Kinesiophobia (TSK-11) Score (time frame: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.