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随机临床试验评估未固定的原发性全髋关节置换柄的迁移,有无自体打压植骨。

Randomised clinical trial assessing migration of uncemented primary total hip replacement stems, with and without autologous impaction bone grafting.

机构信息

Hollywood Private Hospital, Monash Avenue, Perth, WA, 6009, Australia.

The Joint Studio, Suite 1/85 Monash Avenue, Perth, WA, 6009, Australia.

出版信息

Int Orthop. 2019 Dec;43(12):2715-2723. doi: 10.1007/s00264-019-04290-5. Epub 2019 Jan 31.

Abstract

PURPOSE

Uncemented stems in primary total hip replacement (THR) are concerning in the elderly due to ectatic femoral canals and cortical thinning resulting in higher incidence of fracture and subsidence in this population. To obviate this concern, the authors developed a technique using autologous impaction bone grafting to achieve a better fitting femoral stem. The aim of this randomised clinical trial was to assess the efficacy of the technique.

METHODS

From 2013 to 2015, a total of 98 consecutive participants (100 primary THR procedures) were inducted into a single-institution, single-blinded, randomised clinical trial assessing, with radiostereometric analysis (RSA), the efficacy of autologous impaction bone grafting in uncemented primary THR compared with traditional uncemented primary THR technique. The primary outcome measure was femoral component migration using RSA. Secondary outcomes were post-operative proximal femoral bone density (using DEXA), hip function and quality of life using Oxford Hip Score (OHS) and Short Form-12 Health Survey (SF-12), hip pain and patient satisfaction.

RESULTS

There was no difference in femoral component stability (p > 0.5) or calcar resorption between the Graft and No Graft Groups at two years. There was also no difference in OHS, SF-12, pain or satisfaction between the Graft and No Graft Groups at two years (p > 0.39).

CONCLUSIONS

Autologous impaction bone grafting in uncemented primary THR has shown its short-term post-operative outcomes to be equivalent to standard uncemented technique, whilst offering a better fit in patients who are between femoral stem sizes.

AUSTRALIAN CLINICAL TRIAL REGISTRATION NUMBER

ACTRN12618000652279.

摘要

目的

在初次全髋关节置换术(THR)中,非骨水泥股骨柄在老年人中令人担忧,因为扩张的股骨髓腔和皮质变薄导致该人群中骨折和下沉的发生率更高。为了解决这个问题,作者开发了一种使用自体打压植骨技术来获得更好匹配股骨柄的技术。本随机临床试验的目的是评估该技术的疗效。

方法

2013 年至 2015 年,共有 98 名连续患者(100 例初次 THR 手术)纳入一项单中心、单盲、随机临床试验,通过放射学体层摄影测量分析(RSA)评估自体打压植骨在非骨水泥初次 THR 中的疗效与传统非骨水泥初次 THR 技术。主要结局测量指标是 RSA 测量的股骨部件迁移。次要结局是术后股骨近端骨密度(DEXA)、牛津髋关节评分(OHS)和 12 项简短健康调查(SF-12)测量的髋关节功能和生活质量、髋关节疼痛和患者满意度。

结果

在两年时,Graft 组和 No Graft 组在股骨部件稳定性(p>0.5)或距骨吸收方面没有差异。在两年时,Graft 组和 No Graft 组在 OHS、SF-12、疼痛或满意度方面也没有差异(p>0.39)。

结论

非骨水泥初次 THR 中的自体打压植骨在短期术后结果方面与标准非骨水泥技术相当,同时为股骨柄尺寸之间的患者提供更好的匹配。

澳大利亚临床试验注册编号

ACTRN12618000652279。

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