- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07540715
Effect of Intraoperative Live Video Viewing on Kinesiophobia After ACL Reconstruction (VIDEO-ACLR)
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
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Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Konya, Turkey (Türkiye), 42020
- Konya City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 years and older.
- Diagnosis of isolated anterior cruciate ligament (ACL) rupture.
- Scheduled to undergo primary arthroscopic ACL reconstruction under spinal anesthesia.
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Video Viewing Group
Participants view the arthroscopic procedure live on the operating room monitor while under spinal anesthesia
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A patient-centered cognitive intervention providing real-time visual feedback of the reconstructed knee anatomy to mitigate psychological barriers such as kinesiophobia and
Other Names:
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Active Comparator: Control Group
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 |
Routine primary arthroscopic anterior cruciate ligament reconstruction without targeted visual or structured cognitive interventions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tampa Scale of Kinesiophobia (TSK-11) Score
Time Frame: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
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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.
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Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State-Trait Anxiety Inventory (STAI) Score
Time Frame: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
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Postoperative state anxiety is measured using the STAI.
Higher scores indicate greater levels of anxiety.
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Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
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Brief Illness Perception Questionnaire (B-IPQ) Score
Time Frame: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
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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.
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Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively
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Visual Analog Scale (VAS) for Pain
Time Frame: 4 weeks and 24 weeks postoperatively
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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.
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4 weeks and 24 weeks postoperatively
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International Knee Documentation Committee (IKDC) Subjective Knee Form Score
Time Frame: 4 weeks and 24 weeks postoperatively
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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.
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4 weeks and 24 weeks postoperatively
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Lysholm Knee Score
Time Frame: 4 weeks and 24 weeks postoperatively
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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.
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4 weeks and 24 weeks postoperatively
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Short Form-36 (SF-36) Physical Function Subscale Score
Time Frame: 4 weeks and 24 weeks postoperatively
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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.
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4 weeks and 24 weeks postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oğuzhan Pekince, MD, Konya City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEU-ORTHO-ACL-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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