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随机对照试验:人工股骨头置换术与内固定治疗股骨颈骨折的 6 年疗效比较:无显著差异。

Randomized trial of hemiarthroplasty versus internal fixation for femoral neck fractures: no differences at 6 years.

机构信息

Department of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway,

出版信息

Clin Orthop Relat Res. 2014 Jan;472(1):360-7. doi: 10.1007/s11999-013-3245-7. Epub 2013 Aug 24.

DOI:10.1007/s11999-013-3245-7
PMID:23975250
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3889441/
Abstract

BACKGROUND

Hemiarthroplasty has been shown superior to internal fixation for displaced femoral neck fractures (FNF) in the first 2 years. However, there are unanswered questions about the performance of hemiarthroplasty over the longer term compared with internal fixation.

QUESTIONS/PURPOSES: We sought to compare hemiarthroplasty with internal fixation in terms of (1) outcomes scores for pain, hip function, and quality of life at a minimum of 5 years after surgery in a randomized trial. A secondary purpose was to compare (2) patient survival and (3) frequency of reoperation in the two groups.

METHODS

A total of 222 consecutive patients older than 60 years, including those cognitively impaired, with FNF were randomized to either internal fixation with two parallel screws or bipolar hemiarthroplasty. At a minimum followup of 4.9 years (mean, 5.9 years; range, 4.9-7.2 years), 68 of the 70 surviving patients were examined by a study nurse and study physiotherapist blinded to initial treatment. Questionnaires on hip function (Harris hip score), quality of life (Eq5D), and activity of daily living function (Barthel ADL) were administered. The Barthel ADL index score was split into good function (score 95 or 100) and reduced function (score below 95).

RESULTS

The mean survival of the groups was similar with 66.4% (73 of 110) of the patients undergoing hemiarthroplasty and 70.5% (79 of 112) of the patients undergoing internal fixation having died since surgery (p = 0.51). Only 12 of 31 living patients in the internal fixation group had retained their native hips at a mean of 6 years. Between 2 and 6 years, there were two new major reoperations (both in the internal fixation group, for avascular necrosis and deep wound infection). The mean Harris hip score was 66 (SD 19) and 67 (SD 20) in the internal fixation and hemiarthroplasty groups, respectively (p = 0.96). The mean Eq5D index was 0.50 (SD 0.40) in the internal fixation group and 0.34 (SD 0.36) in the hemiarthroplasty group (p = 0.10). Function in terms of ADLs was comparable between the groups; of the patients in the internal fixation group, 42% reported good function on the Barthel ADL index, and the corresponding number in the hemiarthroplasty group was 51% (p = 0.44).

CONCLUSIONS

Hemiarthroplasty has predictable and good long-term results after FNF and is the treatment of choice compared with internal fixation. Further studies will evaluate if total hip arthroplasty has advantages over hemiarthroplasty in patients with fracture with long life expectancy.

摘要

背景

对于移位型股骨颈骨折(FNF),半髋关节置换术在头 2 年内优于内固定。然而,对于半髋关节置换术在长期(超过 2 年)的表现,仍有一些未解决的问题。

问题/目的:我们旨在通过一项随机试验,比较半髋关节置换术与内固定术在以下方面的结果:(1)术后至少 5 年的疼痛、髋关节功能和生活质量评分。次要目的是比较(2)两组患者的生存率和(3)再次手术的频率。

方法

共纳入 222 例年龄大于 60 岁、伴有认知障碍的 FNF 患者,随机分为内固定术(双平行螺钉)或双极半髋关节置换术。在至少 4.9 年(平均 5.9 年;范围 4.9-7.2 年)的随访后,由研究护士和研究物理治疗师对 70 例幸存患者中的 68 例进行检查,这些人员对初始治疗均不知情。进行髋关节功能(Harris 髋关节评分)、生活质量(EQ5D)和日常生活活动功能(巴氏 ADL)的问卷调查。巴氏 ADL 指数评分分为功能良好(评分 95 或 100)和功能降低(评分低于 95)。

结果

两组的平均生存率相似,半髋关节置换组 110 例患者中有 66.4%(73 例)和内固定组 112 例患者中有 70.5%(79 例)死亡(p=0.51)。在接受内固定术的 31 名存活患者中,只有 12 名在平均 6 年后保留了自己的原髋关节。在 2 至 6 年之间,内固定组有 2 例新的主要再手术(均为股骨头缺血性坏死和深部伤口感染)。内固定组的平均 Harris 髋关节评分为 66(SD 19),半髋关节置换组为 67(SD 20)(p=0.96)。内固定组的平均 EQ5D 指数为 0.50(SD 0.40),半髋关节置换组为 0.34(SD 0.36)(p=0.10)。两组的日常生活活动功能相当;在内固定组中,42%的患者报告巴氏 ADL 指数功能良好,而半髋关节置换组的相应比例为 51%(p=0.44)。

结论

半髋关节置换术治疗股骨颈骨折具有可预测的长期良好效果,是内固定术的首选治疗方法。进一步的研究将评估对于预期寿命较长的患者,全髋关节置换术是否优于半髋关节置换术。

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