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约翰·查恩利奖:直接前路与微创后路全髋关节置换术的随机临床试验:哪种方法能带来更好的功能恢复?

John Charnley Award: Randomized Clinical Trial of Direct Anterior and Miniposterior Approach THA: Which Provides Better Functional Recovery?

作者信息

Taunton Michael J, Trousdale Robert T, Sierra Rafael J, Kaufman Ken, Pagnano Mark W

机构信息

Michael J. Taunton MD, Robert T. Trousdale MD, Rafael J. Sierra MD, Ken Kaufman PhD, Mark W. Pagnano MD, Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.

出版信息

Clin Orthop Relat Res. 2018 Feb;476(2):216-229. doi: 10.1007/s11999.0000000000000112.

Abstract

BACKGROUND

The choice of surgical approach for THA remains controversial. Some studies suggest that the direct anterior approach (DAA) leads to less muscle damage than the miniposterior approach (MPA), but there is little high-quality evidence indicating whether this accelerates recovery, or whether this approach-which may be technically more demanding-is associated with component malposition or more complications.

QUESTIONS/PURPOSES: (1) Does the DAA result in faster return to activities of daily living than the MPA? (2) Does the DAA have superior patient-reported outcome measures than the MPA? (3) Does the DAA result in improved radiographic outcomes than the MPA? (4) Does the DAA have a higher risk of complications than the MPA?

METHODS

Between March 1, 2013, and May 31, 2016, 116 patients undergoing primary unilateral THA were randomized to either the DAA or MPA; 15 patients withdrew after randomization, and one died 6 months after surgery from a stroke unrelated to the procedure. Recruitment stopped when 52 patients had been randomized into the DAA group and 49 in the MPA group (n = 101). After patient randomization, one high-volume surgeon performed all of the DAAs and three high-volume surgeons performed the MPA THAs. The groups did not differ in age (65 years; SD 11; range, 38-86 years), sex (52% women), or body mass index (mean 29 kg/m; SD 6 kg/m; range, 21-40 kg/m; all p > 0.40). Functional results included time to discontinue gait aids, discontinue all narcotics, and independence with various activities of daily living; accelerometer data evaluated activity level. Clinical and radiographic outcomes, Hip disability and Osteoarthritis Outcome Score, SF-12, and Harris hip scores to 1 year were also tabulated. The minimum followup was 365 days (mean ± SD, 627 ± 369 days).

RESULTS

There were slight differences in early functional recovery that favored the DAA versus the MPA: time to discontinue walker use (10 versus 15 days, p = 0.01) and time to discontinue all gait aids (17 versus 24 days, p = 0.04). There were no other differences in early functional milestones, although at 2 weeks after surgery, mean steps per day were 3897 (SD 2258; range, 737-11,010) for the DAA versus 2235 for the MPA (SD 1688; range, 27-7450; p < 0.01). There was no difference in activity monitoring at 1 year. There were no differences in patient-reported outcome scores between the groups. There was no difference in the radiographic parameters measured in the two groups, including leg length discrepancy, component position, or offset, and there was no subsidence observed in any hip. There was no difference in complications between the DAA and the MPA groups (8% [four of 52] versus 10% [five of 49]; p = 0.33).

CONCLUSIONS

Both the DAA and MPA approaches provided excellent early recovery with a low risk of complications. Patients undergoing the DAA had a slightly faster recovery, as measured by milestones of function and quantified by activity monitor data, but no substantive differences were evident at 2 months. Because the DAA is the less studied approach, longer term (> 1 year) complications may yet accrue, will be important to quantify, and may offset early benefits.

LEVEL OF EVIDENCE

Level I, therapeutic study.

摘要

背景

全髋关节置换术(THA)手术入路的选择仍存在争议。一些研究表明,直接前路入路(DAA)比微创后外侧入路(MPA)对肌肉的损伤更小,但几乎没有高质量证据表明这是否能加速康复,或者这种技术要求可能更高的入路是否与假体位置不当或更多并发症相关。

问题/目的:(1)与MPA相比,DAA是否能使患者更快恢复日常生活活动?(2)与MPA相比,DAA在患者报告的结局指标方面是否更优?(3)与MPA相比,DAA是否能带来更好的影像学结果?(4)与MPA相比,DAA的并发症风险是否更高?

方法

在2013年3月1日至2016年5月31日期间,116例行初次单侧THA的患者被随机分为DAA组或MPA组;15例患者在随机分组后退出,1例患者在术后6个月因与手术无关的中风死亡。当DAA组有52例患者、MPA组有49例患者被随机分组时(n = 101),招募停止。患者随机分组后,由一名高年资外科医生完成所有DAA手术,三名高年资外科医生完成MPA THA手术。两组在年龄(65岁;标准差11;范围38 - 86岁)、性别(52%为女性)或体重指数(平均29 kg/m²;标准差6 kg/m²;范围21 - 40 kg/m²;所有p > 0.40)方面无差异。功能结果包括停用助行器的时间、停用所有麻醉药品的时间以及各种日常生活活动的独立性;加速度计数据评估活动水平。还列出了至1年时的临床和影像学结果、髋关节功能障碍和骨关节炎结局评分、SF - 12以及Harris髋关节评分。最小随访时间为365天(平均±标准差,627 ± 369天)。

结果

早期功能恢复方面,DAA组与MPA组相比有轻微差异,更有利于DAA组:停用步行器的时间(10天对15天,p = 0.01)和停用所有助行器的时间(17天对24天,p = 0.04)。早期功能里程碑方面无其他差异,尽管在术后2周,DAA组平均每日步数为3897步(标准差2258;范围737 - 11010步),而MPA组为2235步(标准差1688;范围27 - 7450步;p < 0.01)。1年时的活动监测无差异。两组患者报告的结局评分无差异。两组测量的影像学参数无差异,包括肢体长度差异、假体位置或偏心距,且任何髋关节均未观察到下沉。DAA组和MPA组的并发症无差异(8%[52例中的4例]对10%[49例中的5例];p = 0.33)。

结论

DAA和MPA入路均能实现良好的早期恢复,并发症风险低。以功能里程碑衡量并通过活动监测数据量化,接受DAA手术的患者恢复稍快,但在2个月时无明显实质性差异。由于DAA是研究较少的入路,长期(>1年)并发症可能仍会出现,对其进行量化很重要,且可能抵消早期的益处。

证据水平

I级,治疗性研究。

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