The RM Press fit cup™: an investigation in 182 hips at ten-year follow-up.

IF 2.3 3区 医学 Q2 ORTHOPEDICS Orthopaedics & Traumatology-Surgery & Research Pub Date : 2024-09-06 DOI:10.1016/j.otsr.2024.103988
Adrien Portet, Marion Besnard, Carole Ratsimbazafy, Julien Berhouet, Ramy Samargandi, Louis-Romée Le Nail
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引用次数: 0

Abstract

Introduction: For over 10 years, the RM Pressfit cup™ has been used in our department. This is a one-piece, elastic, cementless implant designed with standard polyethylene (PE), covered with a thin coating of titanium particles. To date, there is no French study evaluating this cup after more than 10 years. Therefore, we conducted a retrospective study in order to: (1) evaluate the survival of the implant with a minimum follow-up of 10 years, (2) evaluate the functional scores at the last follow-up, (3) measure the wear of the PE, (4) identify radiological loosening, (5) search for risk factors for cup removal, (6) identify complications that required management in the operating theatre.

Hypothesis: The working hypothesis was that the survival of this implant was greater than 95% at 10 years' follow-up, in accordance with the criteria of the National Institute for Health and Care Excellence (NICE).

Materials and methods: This was a retrospective monocentric study, including adult patients who underwent total hip arthroplasty (THA) with an RM Pressfit cup™ (28 mm friction size) for coxarthrosis (primary or secondary) or femoral head osteonecrosis. Exclusion criteria were a follow-up period of less than 10 years, the placement of an RM Pressfit cup™ as a secondary intention for a THA (n = 5) or following a trochanteric fracture (n = 1). In total, 163 patients (182 hips) with a median age (Q1-Q3) of 63 (56-68) years, and a sex ratio (M/F) of 1.7 were included. Functional scores were evaluated using the Harris and Oxford scores. Radiographs were analyzed in the immediate postoperative period and at the last follow-up.

Results: The median follow-up was 10.5 (10-11.5) years. Of the 182 included hips, 7 cups were removed, corresponding to a 10-year survival rate of 96.1% (95% CI [93.3; 96.9]). The median Harris and Oxford scores at 10.5 years were 95 (90-98) and 19 (17-23) points, respectively. The median PE wear rate was 0.058 (0.039-0.087) mm/year. Univariate analysis showed that male gender was associated with PE wear (OR = 3.6; 95% CI [1.3; 12.9] [p = 0.012]). Ten cups (6%) showed radiological instability with migration greater than 3 mm and/or variation in inclination greater than 8 °, and only 9 hips (6%) showed bone resorption. No preoperative or perioperative factors analyzed were associated with cup removal. Dislocation accounted for 71% (n = 5) of the causes of cup removal. Additionally, 6 hips experienced at least one dislocation episode requiring reduction by external maneuvers in the operating room, bringing the overall dislocation rate in the series to 6% (n = 11). Increased cup inclination was the only risk factor for prosthetic dislocation (OR = 1.2; 95% CI [1.09; 1.4] [p = 0.0003]). Overall complications requiring surgical intervention included 15 (8.3%) implanted cups (7 removed cups, 6 dislocation episodes requiring reduction by external maneuvers in the operating room, and 2 hips reoperated for washing and changing of mobile components due to early infection).

Conclusion: The RM Pressfit cup™ gives good long-term clinical and radiological results with an overall survival of 96.1% and a low complication rate over 10 years. Over the last 2 years the RM Vitamys™ cup has been introduced allowing the use of 32 mm femoral head diameter for size 48 cups, to reduce the risk of dislocation.

Level of evidence: IV; retrospective cohort.

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RM Press fit cup™:对 182 个髋关节十年随访的调查。
介绍:RM Pressfit Cup™ 已在我科使用了 10 多年。这是一种一体式弹性无骨水泥植入体,采用标准聚乙烯(PE)设计,表面覆盖一层薄薄的钛颗粒。迄今为止,法国还没有一项研究对这种髋臼杯使用超过 10 年后的效果进行评估。因此,我们进行了一项回顾性研究,目的是1)评估植入物在至少 10 年的随访中的存活率;2)评估最后一次随访时的功能评分;3)测量 PE 的磨损情况;4)确定放射学松动情况;5)寻找脱杯的风险因素;6)确定需要在手术室处理的并发症:材料与方法:这是一项回顾性的单中心研究:这是一项回顾性单中心研究,研究对象包括因髋关节骨坏死(原发性或继发性)或股骨头坏死而接受 RM Pressfit 杯™(摩擦尺寸为 28 毫米)全髋关节置换术(THA)的成年患者。排除标准包括:随访时间少于 10 年、将 RM Pressfit髋臼杯™ 作为 THA 的次要治疗手段(5 例)或在转子骨折后植入(1 例)。共纳入 163 名患者(182 个髋关节),中位年龄(Q1-Q3)为 63(56-68)岁,性别比(男/女)为 1.7。功能评分采用哈里斯和牛津评分法进行评估。对术后即刻和最后一次随访时的X光片进行了分析:中位随访时间为 10.5(10-11.5)年。在纳入的182个髋关节中,7个髋臼杯被移除,10年存活率为96.1%(95% CI [93.3; 96.9])。10.5年时的Harris和Oxford评分中位数分别为95分(90-98分)和19分(17-23分)。PE磨损率中位数为0.058 (0.039-0.087) mm/年。单变量分析显示,男性性别与 PE 磨损有关(OR = 3.6; 95% CI [1.3; 12.9] (p = 0.012))。10个髋臼杯(6%)出现放射学不稳定性,移位超过3毫米和/或倾斜度变化超过8°,只有9个髋臼(6%)出现骨吸收。所分析的术前或围术期因素均与脱杯无关。脱位占脱杯原因的71%(n = 5)。此外,有6个髋关节至少发生过一次脱位,需要在手术室通过外部手法将其还原,这使得该系列手术的总脱位率达到6%(n = 11)。髋臼杯倾斜度增加是假体脱位的唯一风险因素(OR = 1.2; 95% CI [1.09; 1.4] (p = 0.0003))。需要手术干预的总体并发症包括15个(8.3%)植入的假体杯(7个假体杯被移除,6次脱位需要在手术室通过外部手法还原,2个髋关节因早期感染需要重新手术清洗和更换活动组件):结论:RM Pressfit髋臼杯™具有良好的长期临床和放射学效果,10 年内总存活率为 96.1%,并发症发生率较低。在过去的两年中,RM Vitamys™ 人工关节置换髋臼杯的推出使得 48 号人工关节置换髋臼杯的股骨头直径可以达到 32 毫米,从而降低了脱位的风险:证据级别:IV;回顾性队列。
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来源期刊
CiteScore
5.10
自引率
26.10%
发文量
329
审稿时长
12.5 weeks
期刊介绍: Orthopaedics & Traumatology: Surgery & Research (OTSR) publishes original scientific work in English related to all domains of orthopaedics. Original articles, Reviews, Technical notes and Concise follow-up of a former OTSR study are published in English in electronic form only and indexed in the main international databases.
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