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R3™ delta 陶瓷髋臼系统在全髋关节置换术中的中期结果。

Mid-term outcomes of the R3™ delta ceramic acetabular system in total hip arthroplasty.

机构信息

The Royal Orthopaedic Hospital, NHS Foundation Trust, Bristol Road South, Northfield, Birmingham, B31 2AP, UK.

Department of Orthopedics, HUS Peijaksen sairaala, P.O. Box 900, 00029 HUS, Vantaa, Finland.

出版信息

J Orthop Surg Res. 2021 Jan 9;16(1):35. doi: 10.1186/s13018-020-02192-6.

Abstract

BACKGROUND

Whilst bony fixation of hip replacement has stable solutions, there remains controversy over which bearing best optimizes longevity and function. Ceramic-on-ceramic (CoC) bearing combinations are associated with lower risk of revision due to aseptic loosening and dislocation. Evidence for long-term functional outcomes of modern, 4th generation CoC bearings is limited. The aim of this study was to analyze outcomes and complications of the R3™ Acetabular System (Smith & Nephew, Inc., Cordova, TN, USA) in combination with BIOLOX® Delta ceramic femoral head in patients undergoing primary total hip arthroplasty (THA).

METHODS

Between June 2009 and May 2011, 175 patients (178 hips) were enrolled into a prospective, study at 6 sites in Europe and prospectively followed-up at 3 months and 1, 3, 5, and 7 years postoperative.

RESULTS

Total WOMAC score improved from 63 (range, 22-91) preoperative to 8 (range, 0-8) at 1-year follow-up and remained unchanged at 7-year follow-up. Modified Harris hip score improved from 45 (range, 10-87) preoperative to 83 (range, 25-100) at 3 months, 91 (range, 42-100) at 1 year, and 92 (range, 46, 100) at 7 years. UCLA Activity Rating Scale score improved from 3.3 (range, 1-8) preoperative to 6.2 (range, 2-8) at 1 year; it marginally declined to 5.8 (range, 3-8) at 7-year follow-up. There were 4 trochanteric fractures and 5 patients died of unrelated reasons. Three hips were revised (2 periprosthetic fractures and 1 subluxation). The 7-year cumulative survival rate was 98.3%.

CONCLUSION

Clinical and functional improvements of THA with CoC bearing are maintained at 7 years postoperative.

TRIAL REGISTRATION

ClinicalTrials.Gov, NCT03566082 , Registered 10 January 2018-retrospectively registered.

摘要

背景

虽然髋关节置换的骨固定有稳定的解决方案,但哪种轴承能最好地优化寿命和功能仍存在争议。陶瓷对陶瓷(CoC)轴承组合与无菌性松动和脱位相关的翻修风险较低。关于现代第四代 CoC 轴承的长期功能结果的证据有限。本研究的目的是分析 R3™髋臼系统(Smith & Nephew,Inc.,田纳西州科多瓦)与 BIOLOX®Delta 陶瓷股骨头联合应用于初次全髋关节置换术(THA)患者的结果和并发症。

方法

2009 年 6 月至 2011 年 5 月,在欧洲的 6 个地点进行了一项前瞻性研究,共纳入 175 例患者(178 髋),并在术后 3 个月、1 年、3 年、5 年和 7 年进行前瞻性随访。

结果

WOMAC 总评分从术前的 63(范围:22-91)改善至术后 1 年的 8(范围:0-8),7 年随访时无变化。改良 Harris 髋关节评分从术前的 45(范围:10-87)改善至术后 3 个月的 83(范围:25-100)、术后 1 年的 91(范围:42-100)和术后 7 年的 92(范围:46,100)。UCLA 活动评分从术前的 3.3(范围:1-8)改善至术后 1 年的 6.2(范围:2-8);7 年随访时略有下降至 5.8(范围:3-8)。有 4 例转子间骨折和 5 例患者因其他原因死亡。3 髋翻修(2 例假体周围骨折和 1 例半脱位)。7 年累积生存率为 98.3%。

结论

CoC 轴承 THA 的临床和功能改善可维持至术后 7 年。

试验注册

ClinicalTrials.Gov,NCT03566082,2018 年 1 月 10 日注册-回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/521f/7797157/541a1e988160/13018_2020_2192_Fig1_HTML.jpg

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