双盲、随机、安慰剂对照试验研究方案，评估富血小板血浆增强的前交叉韧带重建肌腱采集后半腱肌功能和发病率。

Study protocol for double-blind, randomised placebo-controlled trial evaluating semitendinosus function and morbidity following tendon harvesting for anterior cruciate ligament reconstruction augmented by platelet-rich plasma.

机构信息

School of Health Sciences and Social Work, Griffith University - Gold Coast Campus, Southport, Queensland, Australia

Griffith Centre of Biomedical and Rehabilitation Engineering (GCORE), Gold Coast, Queensland, Australia.

出版信息

BMJ Open. 2022 Sep 19;12(9):e061701. doi: 10.1136/bmjopen-2022-061701.

DOI:10.1136/bmjopen-2022-061701

PMID:36123079

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9486297/

Abstract

INTRODUCTION

Anterior cruciate ligament (ACL) rupture is debilitating, often requiring surgical reconstruction. An ACL reconstruction (ACLR) using a tendon autograft harvested from the semitendinosus results in substantial injury to the donor muscle. Following ACLR, patients rarely return to their preinjury level of physical activity, are at elevated risk of secondary lower limb injuries and early onset knee osteoarthritis. To date, no randomised controlled trial has evaluated the efficacy of platelet-rich plasma (PRP) in aiding knee function and semitendinosus morphology of following ALCR.

METHODS AND ANALYSIS

This is a multicentre double-blind randomised placebo-controlled trial. Fifty-four ACLR patients aged 18-50 years will be randomised to receive either a single application of PRP (ACLR+) or placebo saline (ACLR) into the semitendinosus harvest zone at the time of surgery. All patients will undergo normal postoperative rehabilitation recommended by the attending orthopaedic surgeon or physiotherapist. The primary outcome measure is between-limb difference (ACLR compared with intact contralateral) in isometric knee flexor strength at 60 knee flexion, collected 10-12 months postsurgery. This primary outcome measure will be statistically compared between groups (ACLR+ and standard ACLR). Secondary outcome measures include bilateral assessments of hamstring muscle morphology via MRI, biomechanical and electromyographic parameters during an anticipated 45° running side-step cut and multidirectional hopping task and patient-reported outcomes questionaries. Additionally, patient-reported outcomes questionaries will be collected before (baseline) as well as immediately after surgery, and at 2-6 weeks, 3-4 months, 10-12 months and 22-24 months postsurgery 10-12 months following surgery.

ETHICS AND DISSEMINATION

Ethics approval has been granted by Griffith University Human Research Ethics Committee, Greenslopes Research and Ethics Committee, and Royal Brisbane & Women's Hospital Human Research Ethics Committee. Results will be submitted for publication in a peer-reviewed medical journal.

TRIAL REGISTRATION NUMBER

ACTRN12618000762257p.

摘要

介绍

前交叉韧带（ACL）撕裂是一种使人虚弱的疾病，常需要手术重建。使用取自半腱肌的肌腱进行 ACL 重建（ACLR）会对供体肌肉造成严重损伤。ACL 重建后，患者很少能恢复到受伤前的身体活动水平，下肢二次受伤和早期膝关节骨关节炎的风险增加。迄今为止，尚无随机对照试验评估富血小板血浆（PRP）在 ACLR 后促进膝关节功能和半腱肌形态方面的疗效。

方法和分析

这是一项多中心、双盲、随机、安慰剂对照试验。将 54 名 18-50 岁的 ACLR 患者随机分为两组，在手术时分别向半腱肌采集区单次应用 PRP（ACLR+）或安慰剂生理盐水（ACLR）。所有患者将接受主治骨科医生或物理治疗师推荐的正常术后康复。主要结局测量指标是术后 10-12 个月时，60 度膝关节屈曲时双侧等长膝关节屈肌力量的差异（ACLR 与对侧完整的差异）。该主要结局指标将在组间（ACLR+和标准 ACLR）进行统计学比较。次要结局指标包括通过 MRI 评估双侧腘绳肌形态、45°跑步侧步切割和多方向跳跃任务期间的生物力学和肌电图参数，以及患者报告的结果问卷。此外，将在术前（基线）以及术后即刻、术后 2-6 周、3-4 个月、10-12 个月和 22-24 个月时收集患者报告的结果问卷。