摘要
背景:盘状半月板是一种罕见的半月板形态异常变异,其发病机制不明。完全型盘状半月板较不完全型盘状半月板更易发生撕裂,也易发生关节退行性改变、骨软骨炎等不良反应,且临床治疗效果不甚满意。关节镜下半月板成形术可加强半月板的稳定性,将提供足够的缓冲压力,防止半月板再次出现撕裂。目的:试验拟观察关节镜下手术治疗盘状半月板的有效性及分析影响疗效的危险因素。方法:研究为单中心、自身对照研究。拟收集2018年12月至2019年12月在安徽医科大学第一附属医院运动创伤与关节镜科的盘状半月板损伤患者196例,采用Stryker公司的关节镜进行关节镜下手术修复,包括半月板成形术和半月板次全切除术,术后随访6-18个月,使用Lysholm评分评价术后疗效并根据末次随访疗效,分为疗效优良组(评分≥85分)及疗效不满意组(评分<85分)。试验经安徽医科大学第一附属医院医学伦理委员会批准(批准号:PJ2018-02-03,审批时间:2018年2月5日),方案版本号1.0。参与试验的患者及其家属应为自愿参加,所有患者均应对试验过程完全知情同意,在充分了解治疗方案的前提下签署"知情同意书"。结果与结论:研究的主要结局指标为应用关节镜下手术治疗患者的末次随访反映膝关节功能Lysholm评分优良率;次要结局指标为术前及末次随访时患者膝关节功能Lysholm评分、关节镜下软骨损伤Outbridge分型结果,膝关节MRI检测形态变化;术前年龄、性别、病变部位及病程;末次随访时不良反应发生率。课题组前期(2015年4月至2016年9月)回顾性分析了115例(115膝)盘状半月板损伤患者的临床资料,随访6-18个月的小样本试验结果发现:(1)盘状半月板破裂关节镜下手术治疗后患者115例术前及末次随访时膝关节Lysholm评分为(65.8±9.39)分及(89.15±7.45)分,差异有显著性意义(P <0.05)。术后Lysholm评分优32例,良61例,可18例,差4例,优良患者例数93例,不满意患者例数22例,Lysholm评分优良率约占80.9%;(2)所有患者术后均未出现膝关节感染,术后存在外侧间隙疼痛4例,2例伴有膝关节外侧不稳;(3)Logistic回归分析结果显示:病程、年龄、软骨损伤分级(Outbridge)是影响关节镜下手术治疗效果的危险因素。试验期望证实,经膝关节镜下手术治疗盘状半月板损伤是一种疗效确切的治疗技术,因患者的年龄及软骨损伤程度与疗效密切相关,建议有症状的盘状半月板损伤患者尽早行手术治疗。试验已在中国临床试验注册中心注册(注册号:ChiCTR1800019182),注册时间:2018年10月30日。
BACKGROUND: Discoid meniscus injury is a rare form of abnormal meniscus morphology with unknown pathogenesis. The complete disc-shaped meniscus is more prone than incomplete disc-shaped meniscus to tearing and adverse reactions such as joint degeneration and osteochondritis. Moreover, its clinical efficacy is not satisfactory. Arthroscopic meniscus surgery can enhance the stability of the meniscus and provide sufficient cushioning pressure to prevent recurrent meniscal tears.OBJECTIVE: To investigate the efficacy of arthroscopic surgery for discoid meniscus injury in knee joint and analyze risk factors that influence the efficacy of arthroscopic surgery.METHODS: This single-center, self-control study, will include 196 patients with discoid meniscus injury who will receive arthroscopic meniscus repair(Stryker) from December 2018 to December 2019 at the Department of Sports Trauma and Arthroscopy, First Affiliated Hospital of Anhui Medical University of China. This surgical procedure will include meniscus plasty and subtotal meniscectomy. After surgery, all included patients will be fol owed up for 6–18 months. Surgical efficacy will be evaluated by Lysholm score. Patients will be divided into an excellent-and-good group(Lysholm score ≥ 85) and a poor group(Lysholm score < 85). This study was approved by the Medical Ethics Committee, First Affiliated Hospital of Anhui Medical University(approval No. PJ2018-02-03) on February 5, 2018. The version of the study protocol is 1.0. Patients and their family members will volunteer to participate in this study. Written informed consent will be obtained from each patient.RESULTS AND CONCLUSION: The primary outcome measure of this study is the change in excellent-and-good rate of Lysholm score that reflects knee joint function measured at the last follow-up in patients undergoing arthroscopic meniscus surgery. Secondary outcome measures are Lysholm score; Outerbridge grade of chondral lesion; knee joint morphology by magnetic resonance images before surgery and at the last follow-up; age, sex, lesion region, and course of disease before surgery; and incidence of adverse reactions at the last follow-up.Clinical data from 115 patients with discoid meniscus injury(115 knees) who received treatment from April 2015 to September 2016 were retrospectively analyzed.(1) Six to eighteen months of follow-up of 115 patients revealed a significant difference in Lysholm scores before surgery(65.8±9.39) and at the last follow-up(89.15±7.45; P < 0.05). Postoperative Lysholm scores were excellent in 32 patients, good in 61 patients, fair in 18 patients, and poor in 4 patients, with an excellent-and-good rate of 80.9%. There were 93 excellent and good patients and22 unsatisfied patients.(2) Knee joint infection did not occur in any patient. There were four patients with lateral interstitial pain and two patients with lateral instability of the knee joint.(3) Logistic regression analysis revealed that course of disease, age, and Outerbridge grade of chondral lesion were risk factors that influenced the efficacy of arthroscopic meniscus surgery. Results from this study hope to confirm that arthroscopic surgery for discoid meniscus injury is a definitive treatment technique. Patient age and the degree of chondral lesion are closely related with efficacy, so it is recommended that patients with symptomatic discoid meniscus injury undergo surgery as soon as possible. This trial had been registered in the Chinese Clinical Trial Registry(registration number: ChiC TR1800019182) on October 30, 2018.
作者
麦剑军
徐斌
涂俊
吴磊
Mai Jianjun;Xu Bin;Tu Jun;Wu Lei(Department of Sports Trauma and Arthroscopy,First Affiliated Hospital of Anhui Medical University,Hefei 230022,Anhui Province,China;Department of Orthopedics,Maanshan People’s Hospital,Maanshan 243000,Anhui Province,China)
出处
《中国组织工程研究》
CAS
北大核心
2019年第4期532-537,共6页
Chinese Journal of Tissue Engineering Research
