Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Anxiety, Kinesiophobia
Conditions
Keywords
Anterior Cruciate Ligament Reconstruction, Kinesiophobia, Intraoperative Video, Visual Biofeedback, Anxiety, Functional Recovery
Brief 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 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
Interventions
BEHAVIORALIntraoperative Live Video Viewing
A patient-centered cognitive intervention providing real-time visual feedback of the reconstructed knee anatomy to mitigate psychological barriers such as kinesiophobia and
PROCEDUREStandard ACL Reconstruction
Routine primary arthroscopic anterior cruciate ligament reconstruction without targeted visual or structured cognitive interventions.
Sponsors
Konya City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, participants, care providers, and the operating surgeon could not be blinded. However, all postoperative psychological and functional assessments were conducted by independent specialists (a psychiatrist and a physical medicine and rehabilitation specialist) who were completely blinded to group allocation. The statistician was also blinded during the primary analysis.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tampa Scale of Kinesiophobia (TSK-11) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory (STAI) Score | Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively | Postoperative state anxiety is measured using the STAI. Higher scores indicate greater levels of anxiety. |
| Brief Illness Perception Questionnaire (B-IPQ) Score | 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. |
| Visual Analog Scale (VAS) for Pain | 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. |
| International Knee Documentation Committee (IKDC) Subjective Knee Form Score | 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. |
| Lysholm Knee Score | 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. |
| Short Form-36 (SF-36) Physical Function Subscale Score | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATOROğuzhan Pekince, MD
Konya City Hospital
Outcome results
None listed