NCT07540715

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

April 14, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

Anterior Cruciate Ligament ReconstructionKinesiophobiaIntraoperative VideoVisual BiofeedbackAnxietyFunctional Recovery

Outcome Measures

Primary Outcomes (1)

  • 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.

    Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively

Secondary Outcomes (6)

  • State-Trait Anxiety Inventory (STAI) Score

    Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively

  • Brief Illness Perception Questionnaire (B-IPQ) Score

    Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively

  • Visual Analog Scale (VAS) for Pain

    4 weeks and 24 weeks postoperatively

  • International Knee Documentation Committee (IKDC) Subjective Knee Form Score

    4 weeks and 24 weeks postoperatively

  • Lysholm Knee Score

    4 weeks and 24 weeks postoperatively

  • +1 more secondary outcomes

Study Arms (2)

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

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

Procedure: Standard ACL Reconstruction

Interventions

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

Also known as: Standard Surgical Care
Control Group

A patient-centered cognitive intervention providing real-time visual feedback of the reconstructed knee anatomy to mitigate psychological barriers such as kinesiophobia and

Also known as: Visual Biofeedback
Video Viewing Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 years and older.
  • Diagnosis of isolated anterior cruciate ligament (ACL) rupture.
  • Scheduled to undergo primary arthroscopic ACL reconstruction under spinal anesthesia.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKinesiophobiaAnxiety Disorders

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesPhobic DisordersMental Disorders

Study Officials

  • Oğuzhan Pekince, MD

    Konya City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 20, 2026

Study Start

January 1, 2023

Primary Completion

April 20, 2025

Study Completion

April 10, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly in order to protect patient privacy and confidentiality. However, aggregate data will be available through publication.

Locations