优化ACL重建中的移植物选择（GRASE ACL）：一项比较股四头肌腱、腘绳肌腱与髌腱用于原发性前交叉韧带断裂患者重建的随机对照临床试验研究方案
简介
丹麦一项三臂随机对照试验（GRASE ACL）纳入150例原发性ACL断裂患者，比较骨-髌腱-骨、腘绳肌腱与股四头肌腱三种自体移植物重建后的临床疗效。研究采用双主要终点设计：12个月IKDC评分行非劣效性检验，等长屈膝力矩发展速率对称指数（RTD-LSI）行优效性检验，随访至术后24个月。该方案为移植物选择研究提供了双终点试验设计范例，结果值得期待。
英文摘要
INTRODUCTION: Anterior cruciate ligament (ACL) reconstruction (ACL-R) is recommended for active patients aiming to return to demanding sports or occupations after ACL rupture. Primary graft options are bone-patellar tendon-bone (BPTB), hamstring tendons (HT) and quadriceps tendon (QT) autografts. However, consensus regarding the optimal graft remains lacking. This trial compares graft selection effects on patient-reported knee function and neuromuscular control after ACL-R. METHODS AND ANALYSIS: The GRASE ACL trial is a single-centre assessor-blinded randomised controlled trial with a three-group parallel design conducted at Copenhagen University Hospital Amager-Hvidovre, Denmark. A total of 150 patients aged 18-40 years with primary ACL rupture are randomised in a 1:1:1 ratio to ACL-R using BPTB, HT or QT autografts. Recruitment was completed in August 2025.The trial uses a dual-primary-outcomes framework evaluated at 12 months. The primary patient-reported outcome is the International Knee Documentation Committee Evaluation Form score, analysed within a non-inferiority framework. The primary biomechanical outcome is the Limb Symmetry Index of Rate of Torque Development (RTD-LSI) during isometric knee flexion, analysed within a superiority framework.Secondary outcomes include patient-reported knee function, return-to-sport and return-to-work outcomes, neuromuscular control, muscle strength, movement biomechanics, clinical knee stability, adverse events and MRI-assessed muscle morphology. Assessments occur at 1, 6, 12, and 24 months postoperatively. ETHICS AND DISSEMINATION: This trial has been approved by the scientific ethics committee for the Capital Region of Denmark and conducted in accordance with the Declaration of Helsinki. Reporting will adhere to Consolidated Standards of Reporting Trials (CONSORT) guidelines and disseminated through peer-reviewed publications and ClinicalTrials.gov updates. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05342441, protocol V.1.5, 24 September 2025, https://clinicaltrials.gov/study/NCT05342441.