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全膝关节置换术中陶瓷和金属股骨部件的前瞻性比较临床研究,随访期为五年。

Prospective comparative clinical study of ceramic and metallic femoral components for total knee arthroplasty over a five-year follow-up period.

作者信息

Bergschmidt Philipp, Ellenrieder Martin, Bader Rainer, Kluess Daniel, Finze Susanne, Schwemmer Benjamin, Mittelmeier Wolfram

机构信息

Department of Traumatology, Orthopaedics and Hand Surgery, Klinikum Südstadt Rostock, Südring 81, 18059 Rostock, Germany; Department of Orthopaedics, University Medicine Rostock, Doberaner Strasse 142, 18057 Rostock, Germany.

Department of Orthopaedics, University Medicine Rostock, Doberaner Strasse 142, 18057 Rostock, Germany.

出版信息

Knee. 2016 Oct;23(5):871-6. doi: 10.1016/j.knee.2016.06.001. Epub 2016 Jun 20.

Abstract

BACKGROUND

The aim of this prospective comparative study was to evaluate the clinical and radiological outcomes of a TKA system, comparing a ceramic (BIOLOX® delta) and metallic (Co28Cr6Mo) femoral component over a five-year follow-up period.

METHODS

Forty-three TKA patients (17 metallic and 26 ceramic femoral components) were enrolled in the study. Clinical and radiological evaluations were performed preoperatively and at three, 12, 24 and 60months postoperatively, using the HSS-, WOMAC- and SF36-Scores, in addition to standardized X-rays.

RESULTS

The HSS-Score improved significantly from 58.7±12.7 points preoperatively to 88.5±12.3 points at five-years postoperative in the ceramic group, and 60.8±7.7 to 86.2±9.4 points in the metallic group. WOMAC- and SF-36-Scores showed significant improvement over time in both groups. There were no significant differences between groups for HSS-, WOMAC- and SF-36-Scores, nor for range of motion (p≤0.897) at any follow-up evaluation. Furthermore, radiological evaluation showed no implant loosening or migration in either group.

CONCLUSIONS

Mid-term outcomes for the ceramic femoral components demonstrated good clinical and radiological results, as well as comparable survivorship to the metallic femoral component of the same total knee system, and to other commonly used metallic total knee systems. Therefore, ceramic knee implants may be a promising solution for the population of patients with osteoarthritis and metal sensitivity. Long-term studies are required in order to confirm the positive mid-term clinical results, and to follow the implant survival rate in regard to the enhanced wear resistance of ceramic implants.

摘要

背景

这项前瞻性比较研究的目的是评估一种全膝关节置换(TKA)系统的临床和放射学结果,在五年的随访期内比较陶瓷(BIOLOX® delta)和金属(Co28Cr6Mo)股骨组件。

方法

43例TKA患者(17例金属股骨组件和26例陶瓷股骨组件)纳入本研究。术前以及术后3个月、12个月、24个月和60个月进行临床和放射学评估,使用HSS评分、WOMAC评分和SF36评分,以及标准化X线检查。

结果

陶瓷组HSS评分从术前的58.7±12.7分显著提高到术后五年的88.5±12.3分,金属组从60.8±7.7分提高到86.2±9.4分。两组的WOMAC评分和SF-36评分均随时间显著改善。在任何随访评估中,两组之间的HSS评分、WOMAC评分和SF-36评分以及活动范围均无显著差异(p≤0.897)。此外,放射学评估显示两组均无植入物松动或移位。

结论

陶瓷股骨组件的中期结果显示出良好的临床和放射学结果,以及与同一全膝关节系统的金属股骨组件和其他常用金属全膝关节系统相当的生存率。因此,陶瓷膝关节植入物可能是骨关节炎和金属敏感患者群体的一个有前景的解决方案。需要进行长期研究以证实中期临床阳性结果,并跟踪陶瓷植入物增强耐磨性方面的植入物存活率。

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