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双动与大直径股骨头在翻修全髋关节置换术中的比较:一项随机对照试验的中期分析。

Dual-Mobility versus Large Femoral Heads in Revision Total Hip Arthroplasty: Interim Analysis of a Randomized Controlled Trial.

机构信息

Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.

Department of Orthopaedic Surgery, Rothman Institute, Philadelphia, Pennsylvania.

出版信息

J Arthroplasty. 2023 Jul;38(7S):S206-S210. doi: 10.1016/j.arth.2023.03.089. Epub 2023 Apr 3.

Abstract

BACKGROUND

This multicenter randomized controlled trial evaluated if dual-mobility bearings (DM) lower the risk of dislocation compared to large femoral heads (≥36 mm) for patients undergoing revision total hip arthroplasty (THA) via a posterior approach.

METHODS

A total of 146 patients were randomized to a DM (n = 76; 46 mm median effective head size, range 36 to 59 mm) or a large femoral head (n = 70; twenty-five 36 mm heads [35.7%], forty-one 40 mm heads [58.6%], and four 44 mm heads [5.7%]). There were 71 single-component revisions (48.6%), 39 both-component revisions (26.7%), 24 reimplantations of THA after 2-stage revision (16.4%), seven isolated head and liner exchanges (4.8%), four conversions of hemiarthroplasty (2.7%), and 1 revision of a hip resurfacing (0.7%). Power analysis determined that 161 patients were required in each group to lower the dislocation rate from 8.4 to 2.2% (power = 0.8, alpha = 0.05).

RESULTS

At a mean of 18.2 months (range, 1.4 to 48.2), there were three dislocations in the large femoral head group compared to two in the DM cohort (4.3 versus 2.6%; P = .67). One patient in the large head group and none in the DM group were successfully treated with closed reduction without subsequent revision.

CONCLUSION

Interim analysis of this randomized controlled trial found no difference in the risk of dislocation between DM and large femoral heads in revision THA, although the rate of dislocation was lower than anticipated and continued follow-up is needed.

摘要

背景

本多中心随机对照试验评估了对于行后路初次全髋关节置换术(THA)翻修的患者,双动(DM)轴承与大直径股骨头(≥36mm)相比,是否降低脱位风险。

方法

共有 146 例患者被随机分配到 DM 组(n=76;中位数有效头尺寸为 46mm,范围 36-59mm)或大直径股骨头组(n=70;25 个 36mm 股骨头[35.7%],41 个 40mm 股骨头[58.6%]和 4 个 44mm 股骨头[5.7%])。其中 71 例为单组件翻修(48.6%),39 例为双组件翻修(26.7%),24 例为 2 期翻修后再次行 THA 翻修(16.4%),7 例为单纯股骨头和衬垫置换(4.8%),4 例为半髋关节置换转换(2.7%),1 例髋关节表面置换翻修(0.7%)。通过功效分析确定每组需要 161 例患者,以将脱位率从 8.4%降低至 2.2%(功效=0.8,α=0.05)。

结果

在平均 18.2 个月(范围,1.4-48.2)时,大直径股骨头组有 3 例脱位,DM 组有 2 例(4.3%比 2.6%;P=0.67)。大直径股骨头组 1 例患者经闭合复位成功治疗,无需进一步翻修,DM 组无患者发生该情况。

结论

该随机对照试验的中期分析显示,在 THA 翻修中,DM 和大直径股骨头之间的脱位风险无差异,尽管脱位率低于预期,仍需要继续随访。

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