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非骨水泥锥形钛合金股骨部件的 27-32 年长期生存率是多少?50 岁以下患者的生存率如何?

What Is the Long-term (27- to 32-year) Survivorship of an Uncemented Tapered Titanium Femoral Component and Survival in Patients Younger Than 50 Years?

机构信息

M. R. Streit, B. Lehner, D. S. Peitgen, M. M. Innmann, G. W. Omlor, T. Walker, C. Merle, B. Moradi, Department of Orthopaedic and Trauma Surgery, University of Heidelberg, Heidelberg, Germany.

M. R. Streit, ARCUS Sportklinik, Pforzheim, Germany.

出版信息

Clin Orthop Relat Res. 2020 Jun;478(6):1283-1291. doi: 10.1097/CORR.0000000000001203.

Abstract

BACKGROUND

Uncemented femoral components in primary THA are in widespread use, especially in patients younger than 50 years, but few studies have evaluated their survival into the late third and early fourth decade.

QUESTIONS/PURPOSES: We evaluated (1) survivorship using femoral revision for any reason as the endpoint, (2) survivorship using femoral revision for aseptic loosening as the endpoint, (3) survival in patients younger than 50 years, (4) cumulative incidence of stem revision for periprosthetic femoral fracture and (5) the overall risk of revision (change of any part of the implanted components) at a minimum of 27 years of follow-up with an uncemented tapered titanium stem still in clinical use today.

METHODS

We reviewed the clinical and radiographic results of 326 THAs performed in 326 patients (for 28 patients with bilateral THA, only the first hip was included in the analysis to ensure independent observations) using an uncemented grit-blasted, tapered collarless titanium alloy (TiAl6Nb7) stem between January 1985 and December 1989. In that same timeframe, we performed 1038 primary THAs. During that time, we used cementless stems in patients without severe femoral canal deformity and adequate bone stock for uncemented femoral fixation as determined by using the indication criteria described by the developer. In all, 34% (354 of 1038) were cementless; all cementless stems implanted during that time were the stem being studied here. No others were used. The mean (range) age at the time of surgery was 56 years (13-81 years). Sixty-seven patients were younger than 50 years at the time of primary THA. A competing risk survivorship analysis was used to estimate long-term survival. The minimum follow-up was 27 years (mean 28 years; range 27-32 years); at that time, 169 patients had died, and four patients were lost to follow-up.

RESULTS

Survivorship at 28 years with revision of the femoral component for any reason as the endpoint was 87% (95% CI 83 to 90). Survivorship for femoral revision for aseptic loosening as the endpoint was 94% at 28 years (95% CI 90 to 96). Survival in patients younger than 50 years at the time of primary THA was 89% (95% CI 78 to 95) and 95% (95% CI 86 to 98) at 28 years for the endpoints of all stem revisions and aseptic stem loosening, respectively. The overall cumulative incidence of stem revision for periprosthetic femoral fracture was 4% (95% CI 2 to 7) at 28 years. The overall THA survival rate at 28 years with revision for any reason as the endpoint was 57% (95% CI 51 to 62).

CONCLUSIONS

Uncemented femoral fixation of a tapered collarless titanium alloy stem was reliable into the early fourth decade, especially in patients younger than 50 years. Late stem failures in the third and early fourth decade were mainly because of periprosthetic femoral fracture, while aseptic loosening occurred in undersized stems during the early second decade.

LEVEL OF EVIDENCE

Level IV, therapeutic study.

摘要

背景

在初次全髋关节置换术(THA)中,非骨水泥股骨假体广泛应用,尤其是在年龄小于 50 岁的患者中,但很少有研究评估其在第三十年和第四十年早期的生存情况。

问题/目的:我们评估了(1)以任何原因进行股骨翻修为终点的生存率,(2)以无菌性松动为终点的股骨翻修生存率,(3)年龄小于 50 岁的患者生存率,(4)股骨假体周围骨折翻修的累计发生率,(5)在最低 27 年的随访中,采用目前仍在临床使用的非骨水泥锥形钛合金柄的整体翻修(任何植入部件的更换)风险,该柄具有磨砂和无领锥形设计。

方法

我们回顾了 1985 年 1 月至 1989 年 12 月期间使用非骨水泥喷砂、锥形无领钛合金(TiAl6Nb7)柄治疗的 326 例 THA(对于双侧 THR 的 28 例患者,仅对第一髋进行分析,以确保独立观察)的临床和影像学结果。在同一时期,我们进行了 1038 例初次 THA。在此期间,我们在没有严重股骨髓腔畸形和足够的非骨水泥股骨固定骨量的患者中使用非骨水泥柄,这是通过使用开发者描述的指征标准来确定的。共有 34%(1038 例中的 354 例)为非骨水泥固定;所有在这段时间内植入的非骨水泥柄均为正在研究的柄。没有使用其他类型的柄。手术时的平均(范围)年龄为 56 岁(13-81 岁)。67 例患者初次 THA 时年龄小于 50 岁。采用竞争风险生存分析来估计长期生存率。最低随访时间为 27 年(平均 28 年;范围 27-32 年);此时,169 例患者死亡,4 例患者失访。

结果

以任何原因进行股骨翻修为终点时,28 年的生存率为 87%(95%CI 83-90)。以无菌性松动为终点时,28 年的股骨翻修生存率为 94%(95%CI 90-96)。初次 THA 时年龄小于 50 岁的患者,分别在所有股骨翻修和无菌性股骨柄松动的终点处,28 年的生存率为 89%(95%CI 78-95)和 95%(95%CI 86-98)。股骨假体周围骨折翻修的总累计发生率为 28 年时的 4%(95%CI 2-7)。以任何原因进行翻修为终点时,28 年的全髋关节生存率为 57%(95%CI 51-62)。

结论

锥形无领钛合金柄的非骨水泥股骨固定在早期第四十年仍然可靠,尤其是在年龄小于 50 岁的患者中。第三十年和第四十年早期的晚期柄失败主要是由于假体周围股骨骨折,而在早期第二十年,无菌性松动发生在尺寸过小的柄中。

证据水平

IV 级,治疗性研究。

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