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Completed

NCT Number: NCT07540715

Effect of Intraoperative Live Video Viewing on Kinesiophobia After ACL Reconstruction

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Intraoperative Live Video Viewing

Behavioral

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: Visual Biofeedback

Standard ACL Reconstruction

Procedure

Routine primary arthroscopic anterior cruciate ligament reconstruction without targeted visual or structured cognitive interventions.

Other names: Standard Surgical Care

Primary outcomes

  1. 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.

Secondary outcomes

  1. State-Trait Anxiety Inventory (STAI) Score

    Time frame: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively

    Postoperative state anxiety is measured using the STAI. Higher scores indicate greater levels of anxiety.

  2. Brief Illness Perception Questionnaire (B-IPQ) Score

    Time frame: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively

    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.

  3. Visual Analog Scale (VAS) for Pain

    Time frame: 4 weeks and 24 weeks postoperatively

    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.

  4. International Knee Documentation Committee (IKDC) Subjective Knee Form Score

    Time frame: 4 weeks and 24 weeks postoperatively

    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.

  5. Lysholm Knee Score

    Time frame: 4 weeks and 24 weeks postoperatively

    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.

  6. Short Form-36 (SF-36) Physical Function Subscale Score

    Time frame: 4 weeks and 24 weeks postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Impact of Intraoperative Live Arthroscopic Video Viewing on Kinesiophobia and Functional Outcomes After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

Acronym: VIDEO-ACLR

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 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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