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开放性与关节镜下肩袖修补术的有效性(UKUFF):一项随机对照试验。

Effectiveness of open and arthroscopic rotator cuff repair (UKUFF): a randomised controlled trial.

作者信息

Carr A, Cooper C, Campbell M K, Rees J, Moser J, Beard D J, Fitzpatrick R, Gray A, Dawson J, Murphy J, Bruhn H, Cooper D, Ramsay C

机构信息

University of Oxford, Botnar Research Centre, Windmill Road, Headington, Oxford OX3 7LD, UK.

University of Aberdeen, Health Services Research Unit, Foresterhill, Aberdeen, AB25 2ZD, UK.

出版信息

Bone Joint J. 2017 Jan;99-B(1):107-115. doi: 10.1302/0301-620X.99B1.BJJ-2016-0424.R1.

Abstract

AIMS

The appropriate management for patients with a degenerative tear of the rotator cuff remains controversial, but operative treatment, particularly arthroscopic surgery, is increasingly being used. Our aim in this paper was to compare the effectiveness of arthroscopic with open repair of the rotator cuff.

PATIENTS AND METHODS

A total of 273 patients were recruited to a randomised comparison trial (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and general hospitals in the United Kingdom. The surgeons used their usual preferred method of repair. The Oxford Shoulder Score (OSS), two years post-operatively, was the primary outcome measure. Imaging of the shoulder was performed at one year after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283.

RESULTS

The mean OSS improved from 26.3 (standard deviation (sd) 8.2) at baseline, to 41.7 (sd 7.9) two years post-operatively for arthroscopic surgery and from 25.0 (sd 8.0) to 41.5 (sd 7.9) for open surgery. Intention-to-treat (ITT) analysis showed no statistical difference between the groups at two years (difference in OSS score -0.76; 95% confidence interval (CI) -2.75 to 1.22; p = 0.452). The confidence interval excluded the pre-determined clinically important difference in the OSS of three points. The rate of re-tear was not significantly different between the two groups (46.4% for arthroscopic and 38.6% for open surgery; 95% CI -6.9 to 25.8; p = 0.256). Healed repairs had the most improved OSS. These findings were the same when analysed per-protocol.

CONCLUSION

There is no evidence of difference in effectiveness between open and arthroscopic repair of rotator cuff tears. The rate of re-tear is high in both groups, for all sizes of tear and ages and this adversely affects the outcome. Cite this article: Bone Joint J 2017;99-B:107-15.

摘要

目的

对于肩袖退变撕裂患者的恰当治疗仍存在争议,但手术治疗,尤其是关节镜手术,应用越来越广泛。本文的目的是比较关节镜下肩袖修补术与开放修补术的疗效。

患者与方法

从英国19家教学医院和综合医院招募了273例患者,进行一项随机对照试验(136例行关节镜手术,137例行开放手术)。外科医生采用他们常用的首选修补方法。术后两年的牛津肩评分(OSS)是主要结局指标。术后一年对肩部进行影像学检查。该试验已在当前对照试验注册,注册号为ISRCTN97804283。

结果

关节镜手术组患者的平均OSS从基线时的26.3(标准差(sd)8.2)提高到术后两年的41.7(sd 7.9),开放手术组从25.0(sd 8.0)提高到41.5(sd 7.9)。意向性分析(ITT)显示两组在两年时无统计学差异(OSS评分差异为-0.76;95%置信区间(CI)为-2.75至1.22;p = 0.452)。置信区间排除了预先确定的OSS三分临床重要差异。两组的再撕裂率无显著差异(关节镜手术组为46.4%,开放手术组为38.6%;95%CI为-6.9至25.8;p = 0.256)。愈合的修补术使OSS改善最大。按方案分析时结果相同。

结论

没有证据表明肩袖撕裂的开放修补术和关节镜修补术在疗效上存在差异。两组中各种大小撕裂和各年龄段的再撕裂率都很高,这对结局有不利影响。引用本文:《骨与关节杂志》2017年;99-B:107 - 15。

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