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经骨髓腔通风术修复不稳定、完全性垂直半月板撕裂:一项前瞻性、随机、双盲、平行分组、安慰剂对照研究。

Repair Augmentation of Unstable, Complete Vertical Meniscal Tears With Bone Marrow Venting Procedure: A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study.

机构信息

Department of Musculoskeletal Trauma Surgery and Orthopaedics, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital, Otwock, Poland.

Department of Musculoskeletal Trauma Surgery and Orthopaedics, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital, Otwock, Poland.

出版信息

Arthroscopy. 2019 May;35(5):1500-1508.e1. doi: 10.1016/j.arthro.2018.11.056. Epub 2019 Mar 20.

Abstract

PURPOSE

To compare the effectiveness and safety of meniscal repair in 2 groups of patients: meniscal repair with biological augmentation using a bone marrow venting procedure (BMVP) of the intercondylar notch versus meniscal repair only.

METHODS

This single-center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 40 patients (21 menisci in control, 23 in BMVP group) with complete vertical meniscus tears. Patients underwent all-inside and outside-in meniscal repair and a concomitant BMVP of the intercondylar notch or meniscal repair alone during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the 2 groups assessed during a second-look arthroscopy (at week 35). The secondary endpoints were changes in the International Knee Documentation Committee score, Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, and visual analog scale in the 2 groups at 30 months.

RESULTS

After 36 weeks, the meniscus healing rate was significantly higher in the BMVP-treated group than in the control group (100% vs. 76%, P = .0035). Functional outcomes were significantly better 30 months after treatment than at baseline in both groups. The International Knee Documentation Committee, Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, and visual analog scale scores were significantly better in the BMVP-treated group than in the control group. No adverse events were reported during the study period.

CONCLUSIONS

Our blinded, prospective, randomized, controlled trial on the role of BMVP augmentation in meniscus repair, indicates that BMVP augmentation results in a significant improvement in the rate of meniscus healing (100% vs. 76%, P = .0035). The risk of adverse events related to augmentation with BMVP of the arthroscopic meniscal repair is very low.

LEVEL OF EVIDENCE

Level I, randomized controlled trial.

摘要

目的

比较两组患者半月板修复的有效性和安全性:使用骨道开窗术(BMVP)进行骨道开窗术(BMVP)的半月板修复与单纯半月板修复。

方法

这项单中心、前瞻性、随机、双盲、安慰剂对照、平行臂研究纳入了 40 名患者(对照组 21 个半月板,BMVP 组 23 个半月板),均为完全垂直半月板撕裂。患者在索引关节镜检查中均接受了全内和外-内半月板修复以及相应的髁间窝 BMVP 或单独的半月板修复。主要终点是两组患者在第二次关节镜检查时(第 35 周)半月板愈合率。次要终点是两组患者在 30 个月时国际膝关节文献委员会评分、膝关节损伤和骨关节炎结果评分、西安大略和麦克马斯特大学骨关节炎指数和视觉模拟评分的变化。

结果

36 周后,BMVP 治疗组的半月板愈合率明显高于对照组(100%比 76%,P=0.0035)。两组患者的功能结局在治疗后 30 个月均明显优于基线。BMVP 治疗组的国际膝关节文献委员会评分、膝关节损伤和骨关节炎结果评分、西安大略和麦克马斯特大学骨关节炎指数和视觉模拟评分均明显优于对照组。研究期间未报告不良事件。

结论

我们对 BMVP 增强半月板修复作用的盲法、前瞻性、随机、对照试验表明,BMVP 增强可显著提高半月板愈合率(100%比 76%,P=0.0035)。与 BMVP 增强关节镜半月板修复相关的不良事件风险非常低。

证据水平

一级,随机对照试验。

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