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中年患者退行性半月板撕裂的运动疗法与关节镜下半月板部分切除术对比:两年随访的随机对照试验

Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up.

作者信息

Kise Nina Jullum, Risberg May Arna, Stensrud Silje, Ranstam Jonas, Engebretsen Lars, Roos Ewa M

机构信息

Department of Orthopaedic Surgery, Martina Hansens Hospital, PO box 823, N-1306 Sandvika, Norway

Norwegian Research Centre for Active Rehabilitation, Oslo, Norway Division of Orthopaedic Surgery, Oslo University Hospital, Norway Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.

出版信息

BMJ. 2016 Jul 20;354:i3740. doi: 10.1136/bmj.i3740.

Abstract

OBJECTIVE

To determine if exercise therapy is superior to arthroscopic partial meniscectomy for knee function in middle aged patients with degenerative meniscal tears.

DESIGN

Randomised controlled superiority trial.

SETTING

Orthopaedic departments at two public hospitals and two physiotherapy clinics in Norway.

PARTICIPANTS

140 adults, mean age 49.5 years (range 35.7-59.9), with degenerative medial meniscal tear verified by magnetic resonance imaging. 96% had no definitive radiographic evidence of osteoarthritis.

INTERVENTIONS

12 week supervised exercise therapy alone or arthroscopic partial meniscectomy alone.

MAIN OUTCOME MEASURES

Intention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two year follow-up and change in thigh muscle strength from baseline to three months.

RESULTS

No clinically relevant difference was found between the two groups in change in KOOS4 at two years (0.9 points, 95% confidence interval -4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two year follow-up, with no additional benefit.

CONCLUSION

The observed difference in treatment effect was minute after two years of follow-up, and the trial's inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short term. Our results should encourage clinicians and middle aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option.Trial registration www.clinicaltrials.gov (NCT01002794).

摘要

目的

确定运动疗法对于患有退行性半月板撕裂的中年患者的膝关节功能是否优于关节镜下部分半月板切除术。

设计

随机对照优势试验。

地点

挪威两家公立医院和两家物理治疗诊所的骨科。

参与者

140名成年人,平均年龄49.5岁(范围35.7 - 59.9岁),经磁共振成像证实患有退行性内侧半月板撕裂。96%的人没有明确的骨关节炎影像学证据。

干预措施

单独进行为期12周的监督运动疗法或单独进行关节镜下部分半月板切除术。

主要结局指标

意向性分析两组之间膝关节损伤和骨关节炎结局评分(KOOS4)变化的组间差异,预先定义为从基线到两年随访期间KOOS五个子量表评分(疼痛、其他症状、运动和娱乐功能以及与膝关节相关的生活质量)中五个中的四个的平均评分,以及从基线到三个月大腿肌肉力量的变化。

结果

两组在两年时KOOS4变化方面未发现临床相关差异(0.9分,95%置信区间 -4.3至6.1;P = 0.72)。在三个月时,运动组的肌肉力量有所改善(P≤0.004)。在两年随访期间,两组均未发生严重不良事件。在两年随访期间,分配到运动疗法组的参与者中有19%转而接受手术,未获得额外益处。

结论

经过两年随访,观察到的治疗效果差异微小,且试验的推断不确定性足够小,可排除临床相关差异。运动疗法在改善大腿肌肉力量方面至少在短期内显示出比手术更积极的效果。我们的结果应鼓励临床医生以及患有退行性半月板撕裂且无明确骨关节炎影像学证据的中年患者将监督运动疗法作为一种治疗选择。试验注册 网址:www.clinicaltrials.gov(NCT01002794)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d512/4957588/afdec5ad7873/kisn030744.f1_default.jpg

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