Orthopaedic Research Institute of Queensland, 7 Turner Street, Pimlico, Townsville, QLD, 4812, Australia.
Department of Orthopaedics, Townsville Hospital, Townsville, Australia.
Musculoskelet Surg. 2021 Dec;105(3):257-264. doi: 10.1007/s12306-020-00651-1. Epub 2020 Mar 2.
Total hip arthroplasty is a successful treatment for hip osteoarthritis. Primary and secondary implant fixation is dependent on implant design and plays an important role in the longevity of an implant. In this study, we assessed the self-locking cementless Master femoral stem.
In this single-centre prospective study, 50 consecutive hips with the indication for total hip arthroplasty, who met the inclusion criteria, received the Master stem from LIMA Corporate. Patients had pre- and post-operative clinical and radiological assessment and completed patient-reported outcome measures [Oxford Hip Score (OHS), Harris Hip Score (HHS) and Forgotten Joint Score (FJS)] at the 6-week and 6-, 12- and 24-month mark. Post-operative X-rays were assessed for osteointegration (Engh Score), alignment and subsidence.
After 2 years, aseptic survival was 100%. One hip had to be explanted due to early deep infection and was excluded from the study. At 2 years, the patients reported a significant improved HHS and OHS of 95.3 ± 5.8 and 46.1 ± 3.6 (mean ± standard deviation), respectively, compared to preoperatively. The mean ± standard deviation for the FJS was 86.4 ± 18.7 with two-thirds of the patients reporting a score above 85. The mean Engh score is 15.1 ± 5.9 (mean ± standard deviation) with no patient scoring below 1 which suggests good osteointegration in all femoral stems.
The Master femoral stem performed well in this short-term follow-up study, with high patient satisfaction and good signs of osteointegration. Long-term follow-up will be necessary to evaluate longevity.
Level 3, Prospective cohort study.
The study was registered on the 30.03.2016 with Australia New Zealand Clinical Trials Registry (ACTRN12617000550303).
全髋关节置换术是治疗髋关节骨关节炎的一种成功方法。初次和二次植入物固定取决于植入物设计，并在植入物的使用寿命中起着重要作用。在这项研究中，我们评估了自锁型非骨水泥 Master 股骨柄。
在这项单中心前瞻性研究中，符合纳入标准的 50 例连续髋关节接受了来自 LIMA Corporate 的 Master 股骨柄。患者接受了术前和术后的临床和放射学评估，并在 6 周、6、12 和 24 个月时完成了患者报告的结局测量[牛津髋关节评分（OHS）、Harris 髋关节评分（HHS）和遗忘关节评分（FJS）]。术后 X 射线评估了骨整合（Engh 评分）、对线和下沉情况。
2 年后，无菌生存率为 100%。1 例因早期深部感染而不得不取出髋关节，被排除在研究之外。2 年后，患者报告 HHS 和 OHS 分别显著改善至 95.3±5.8 和 46.1±3.6（均值±标准差），与术前相比。FJS 的均值±标准差为 86.4±18.7，三分之二的患者报告评分高于 85。平均 Engh 评分是 15.1±5.9（均值±标准差），没有患者评分低于 1，这表明所有股骨柄均有良好的骨整合。
在这项短期随访研究中，Master 股骨柄表现良好，患者满意度高，有良好的骨整合迹象。需要长期随访来评估其长期效果。
3 级，前瞻性队列研究。
该研究于 2016 年 3 月 30 日在澳大利亚和新西兰临床试验注册中心（ACTRN12617000550303）注册。
