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关节镜下半月板部分切除术治疗退行性半月板撕裂:FIDELITY(芬兰退行性半月板病变研究)试验安慰剂手术对照的 5 年随访。

Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial.

机构信息

Department of Orthopaedics and Traumatology, Pihlajalinna Oyj, Tampere, Pirkanmaa, Finland.

Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.

出版信息

Br J Sports Med. 2020 Nov;54(22):1332-1339. doi: 10.1136/bjsports-2020-102813. Epub 2020 Aug 27.

Abstract

OBJECTIVES

To assess the long-term effects of arthroscopic partial meniscectomy (APM) on the development of radiographic knee osteoarthritis, and on knee symptoms and function, at 5 years follow-up.

DESIGN

Multicentre, randomised, participant- and outcome assessor-blinded, placebo-surgery controlled trial.

SETTING

Orthopaedic departments in five public hospitals in Finland.

PARTICIPANTS

146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised.

INTERVENTIONS

APM or placebo surgery (diagnostic knee arthroscopy).

MAIN OUTCOME MEASURES

We used two indices of radiographic knee osteoarthritis (increase in Kellgren and Lawrence grade ≥1, and increase in Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score, respectively), and three validated patient-relevant measures of knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale).

RESULTS

There was a consistent, slightly greater risk for progression of radiographic knee osteoarthritis in the APM group as compared with the placebo surgery group (adjusted absolute risk difference in increase in Kellgren-Lawrence grade ≥1 of 13%, 95% CI -2% to 28%; adjusted absolute mean difference in OARSI sum score 0.7, 95% CI 0.1 to 1.3). There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively. The corresponding adjusted absolute risk difference in the presence of mechanical symptoms was 18% (95% CI 5% to 31%); there were more symptoms reported in the APM group. All other secondary outcomes comparisons were similar.

CONCLUSIONS

APM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 years after surgery.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT01052233 and NCT00549172).

摘要

目的

评估关节镜下半月板部分切除术(APM)对放射学膝关节骨关节炎的长期影响,以及对膝关节症状和功能的影响,随访时间为 5 年。

设计

多中心、随机、参与者和结果评估者双盲、安慰剂手术对照试验。

地点

芬兰五家公立医院的矫形外科部门。

参与者

146 名成年人,平均年龄 52 岁(35-65 岁),膝关节症状符合内侧半月板撕裂的退行性改变,经 MRI 扫描和关节镜检查证实,且无膝关节骨关节炎的临床体征,被随机分组。

干预措施

APM 或安慰剂手术(诊断性膝关节关节镜检查)。

主要观察指标

我们使用了两种放射学膝关节骨关节炎的指标(Kellgren 和 Lawrence 分级增加≥1 级,以及 Osteoarthritis Research Society International(OARSI)图谱放射学关节间隙狭窄和骨赘总和评分增加),以及三种经过验证的与患者相关的膝关节症状和功能指标(Western Ontario Meniscal Evaluation Tool( WOMET)、Lysholm 和运动后膝关节疼痛的数字评分量表)。

结果

与安慰剂手术组相比,APM 组的放射学膝关节骨关节炎进展风险持续且略高(Kellgren-Lawrence 分级增加≥1 级的调整绝对风险差异为 13%,95%CI-2%至 28%;OARSI 总和评分的调整平均差异为 0.7,95%CI 0.1 至 1.3)。在三个患者报告的结果中,两组之间没有相关的差异:调整后的平均差异(APM 与安慰剂手术),WOMET 为-1.7(95%CI-7.7 至 4.3),Lysholm 膝关节评分-2.1(95%CI-6.8 至 2.6),运动后膝关节疼痛为-0.04(95%CI-0.81 至 0.72)。机械症状存在时,相应的调整绝对风险差异为 18%(95%CI 5%至 31%);APM 组报告的症状更多。所有其他次要结局比较均相似。

结论

APM 与放射学膝关节骨关节炎的风险增加相关,且在手术后 5 年时,与患者相关的结局没有伴随获益。

试验注册

ClinicalTrials.gov(NCT01052233 和 NCT00549172)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46ac/7606577/685cf90ecbcd/bjsports-2020-102813f01.jpg

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