Impact of Intraoperative Live Arthroscopic Video Viewing on Kinesiophobia and Functional Outcomes After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Tampa Scale of Kinesiophobia (TSK-11) Score
研究概览
简要总结
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
.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years and older.
- •Diagnosis of isolated anterior cruciate ligament (ACL) rupture.
- •Scheduled to undergo primary arthroscopic ACL reconstruction under spinal anesthesia.
排除标准
- •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)
研究组 & 干预措施
Video Viewing Group
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
干预措施: Intraoperative Live Video Viewing (Behavioral)
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
干预措施: Standard ACL Reconstruction (Procedure)
结局指标
主要结局
Tampa Scale of Kinesiophobia (TSK-11) Score
时间窗: 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.
次要结局
- 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)
- Short Form-36 (SF-36) Physical Function Subscale Score(4 weeks and 24 weeks postoperatively)
研究者
Oğuzhan PEKİNCE
MD
Konya City Hospital
