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55岁以下同一患者群体中超短型与传统解剖型非骨水泥股骨柄的对比研究

Ultrashort versus Conventional Anatomic Cementless Femoral Stems in the Same Patients Younger Than 55 Years.

作者信息

Kim Young-Hoo, Park Jang-Won, Kim Jun-Shik

机构信息

The Joint Replacement Center, SeoNam Hospital, Ewha Womans University, #20, Sinjeongipen 1-ro, YangCheon-gu, Seoul, 158-070, Republic of Korea.

The Joint Replacement Center, MokDong Hospital, Ewha Womans University, Seoul, Republic of Korea.

出版信息

Clin Orthop Relat Res. 2016 Sep;474(9):2008-17. doi: 10.1007/s11999-016-4902-4. Epub 2016 Jun 3.

Abstract

BACKGROUND

Because the clinical and radiographic performance of an ultrashort anatomic cementless stem has been investigated in only two randomized controlled studies, well-designed trials should aim for a thorough comparison of the outcomes of ultrashort anatomic cementless and conventional anatomic cementless stems.

QUESTIONS/PURPOSES: The purposes of this study were to compare (1) the clinical results, including Harris hip score, thigh pain, and WOMAC index score, (2) radiographic results, (3) bone mineral density; and (4) proportions of patients undergoing revision of a THA using an ultrashort anatomic cementless stem versus a conventional anatomic cementless stem in the same patients who underwent bilateral sequential THAs under the same anesthetic.

METHODS

Two hundred patients (mean age, 53 years; range, 26-54 years) who underwent bilateral sequential THAs received an ultrashort anatomic cementless stem in one hip and a conventional anatomic cementless stem in the contralateral hip. From January 2004 to December 2005, we performed 524 same-day bilateral short and conventional anatomic cementless THAs in 262 patients, of whom 212 (81%) participated in this study. Five patients were lost to followup before 2 years, five were lost between 2 to 10 years, and two were lost between 10 to 13 years, leaving 200 patients. Patients who had end-stage bilateral hip disease and were younger than 55 years were selected for inclusion. The predominant diagnoses were osteonecrosis (118 patients, 59%) and osteoarthritis (44 patients, 22%). One hundred thirty-eight were men and 62 were women. At the time of each followup, the patients were assessed clinically and radiographically. In addition, each patient completed the WOMAC and the University of California Los Angeles (UCLA) activity scores. The minimum followup was 10 years (mean, 11.8 years; range, 10-13 years). Followups were done in person, with all images and followup clinic notes. Based on the power analysis, we estimated a sample size of 178 hips was needed in each group to detect a 3-point difference in the Harris hip score with 80% power.

RESULTS

At the latest followup, there were no differences between the two groups regarding the mean Harris hip scores (94 versus 94 points; p = 0.189), mean WOMAC scores (17 versus 16 points; p = 0.191), or mean UCLA activity scores (9 versus 9 points; p = 0.381). Two patients in the ultrashort stem group and one patient in the conventional stem group had severe (9 points) thigh pain, and 30 patients (15%) in the conventional stem group had mild thigh pain (2 or 3 points) after vigorous exercise. Bone mineral density in the ultrashort and conventional stem groups, respectively, was greater in the ultrashort stem group than in the conventional stem group. Bone mineral density in Zone 1 at 12 years was 3.29 versus 1.88 g/cm(2) (p = 0.021), and 2.97 versus 0.91 g/m(2) in Zone 7 (p = 0.001). With the numbers available, there were no differences between the stem designs in terms of the proportion undergoing revision (one hip, 0.5%, in the short-stem group versus one hip, 0.5%, in the conventional group; p = 1.881).

CONCLUSIONS

At followup into the second decade, ultrashort stems showed no differences from conventional cementless stems in terms of validated outcomes scores or fixation, although less stress shielding was observed. Reduction of stress shielding may reduce the long-term risk of periprosthetic fracture, but this was not shown in our study.

LEVEL OF EVIDENCE

Level I, therapeutic study.

摘要

背景

由于仅在两项随机对照研究中对超短解剖型非骨水泥柄的临床和影像学表现进行了研究,因此设计良好的试验应旨在全面比较超短解剖型非骨水泥柄与传统解剖型非骨水泥柄的治疗结果。

问题/目的:本研究的目的是比较:(1)临床结果,包括Harris髋关节评分、大腿疼痛和WOMAC指数评分;(2)影像学结果;(3)骨密度;(4)在同一患者双侧序贯全髋关节置换术中,使用超短解剖型非骨水泥柄与传统解剖型非骨水泥柄进行全髋关节置换翻修的患者比例。

方法

200例(平均年龄53岁;范围26 - 54岁)接受双侧序贯全髋关节置换术的患者,一侧髋关节植入超短解剖型非骨水泥柄,对侧髋关节植入传统解剖型非骨水泥柄。2004年1月至2005年12月,我们在262例患者中进行了524例同日双侧短柄和传统解剖型非骨水泥全髋关节置换术,其中212例(81%)参与了本研究。5例患者在2年之前失访,5例在2至10年之间失访,2例在10至13年之间失访,最终留下200例患者。纳入年龄小于55岁的终末期双侧髋关节疾病患者。主要诊断为骨坏死(118例患者,59%)和骨关节炎(44例患者,22%)。男性138例,女性62例。每次随访时,对患者进行临床和影像学评估。此外,每位患者完成WOMAC和加利福尼亚大学洛杉矶分校(UCLA)活动评分。最短随访时间为10年(平均11.8年;范围10 - 13年)。随访均为亲自进行,包括所有影像资料和随访门诊记录。根据功效分析,我们估计每组需要178个髋关节的样本量,以80%的功效检测Harris髋关节评分3分的差异。

结果

在最近一次随访时,两组在平均Harris髋关节评分(94分对94分;p = 0.189)、平均WOMAC评分(17分对16分;p = 0.191)或平均UCLA活动评分(9分对9分;p = 0.381)方面无差异。超短柄组有2例患者和传统柄组有1例患者出现严重(9分)大腿疼痛,传统柄组有30例患者(15%)在剧烈运动后出现轻度大腿疼痛(2或3分)。超短柄组的骨密度在超短柄组和传统柄组中分别更高。12年时1区的骨密度为每平方厘米3.29克对1.88克(p = 0.021),7区为每平方米2.97克对0.91克(p = 0.001)。就现有数据而言,两种柄设计在翻修比例方面无差异(短柄组1例髋关节,0.5%,传统组1例髋关节,0.5%;p = 1.881)。

结论

在随访至第二个十年时,超短柄在验证的结果评分或固定方面与传统非骨水泥柄无差异,尽管观察到应力遮挡较少。应力遮挡的减少可能会降低假体周围骨折的长期风险,但在我们的研究中未显示。

证据水平

I级,治疗性研究。

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