Lin Yanming, Zhao Jiasong, Qiu Heng, Huang Yong
Department of Orthopaedics, Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan 610072, China.
Medicine (Baltimore). 2020 Jul 2;99(27):e20688. doi: 10.1097/MD.0000000000020688.
With advancements in our understanding of meniscal function, treatment options for meniscal injuries have evolved considerably over the past few decades. The aim of the current study was to compare the all-inside and inside-out techniques with regard to retear rate, functional outcomes, and perioperative complications in patients who had undergone arthroscopic meniscus repair. We hypothesized that there was no significant difference between the 2 groups in terms of postoperative outcomes after arthroscopic meniscus repair.
This study was a prospective randomized blinded study, with a parallel design and an allocation ratio of 1:1 for the treatment groups. This study was approved by the Institutional Review Board in our hospital and written informed consent was obtained from all subjects participating in the trial. It was carried out in accordance with the principles of the Helsinki Declaration. A total of 70 patients who meet inclusion criteria are randomized to either all-inside or inside-out group. The primary outcome measure was retear rate. Retear was determined by repeat arthroscopic evaluation of patients with follow-up for symptoms of persistent or new pain, catching, or locking that was possibly related to the meniscal repair. Secondary outcomes included disease-specific quality of life measurement with the Western Ontario Meniscal Evaluation Tool, range of motion, operative time, and adverse events at surgery or throughout the follow-up period.
This study has limited inclusion and exclusion criteria and a well-controlled intervention.
This study protocol was registered in Research Registry (researchregistry5589).
随着我们对半月板功能认识的进步，在过去几十年里，半月板损伤的治疗选择有了很大发展。本研究的目的是比较全关节镜下和由外向内技术在关节镜下半月板修复患者中的再撕裂率、功能结局及围手术期并发症。我们假设在关节镜下半月板修复术后，两组在术后结局方面无显著差异。
本研究为前瞻性随机双盲研究，采用平行设计，治疗组分配比例为1:1。本研究经我院机构审查委员会批准，所有参与试验的受试者均获得了书面知情同意。研究按照《赫尔辛基宣言》的原则进行。共有70例符合纳入标准的患者被随机分为全关节镜下组或由外向内组。主要结局指标为再撕裂率。通过对有持续或新发疼痛、卡顿或绞锁症状（可能与半月板修复有关）的患者进行重复关节镜评估来确定再撕裂情况。次要结局包括使用西安大略半月板评估工具进行的疾病特异性生活质量测量、活动范围、手术时间以及手术或整个随访期间的不良事件。
本研究纳入和排除标准有限，干预措施控制良好。
本研究方案已在研究注册库（researchregistry5589）注册。
