Hamilton David F, Gaston Paul, Macpherson Gavin J, Simpson Philip, Clement Nick D
School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.
Department of Orthopaedics, University of Edinburgh, Edinburgh, UK.
Bone Jt Open. 2023 Oct 18;4(10):782-790. doi: 10.1302/2633-1462.410.BJO-2023-0052.
The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, health-related quality of life, and radiological signs of loosening of the acetabular component.
A single-centre, prospective cohort study of 125 implants will be undertaken. Patients undergoing hybrid THA at the study centre will be recruited. Inclusion criteria are patients suitable for the use of the uncemented acetabular component, aged 18 to 75 years, willing and able to comply with the study protocol, and provide informed consent. Exclusion criteria includes patients not meeting study inclusion criteria, inadequate bone stock to support fixation of the prosthesis, a BMI > 40 kg/m, or THA performed for pain relief in those with severely restricted mobility.
Implant survival, complications, functional outcomes and radiological assessment up to ten years following index THA (one, two, five, seven, and ten years) will be performed. Functional assessment will include the Oxford Hip Score, Forgotten Joint Score, 12-Item Short Form Health Survey, EuroQol five-dimension health questionnaire, and pain and patient satisfaction. Radiological assessment with assess for acetabula lucent lines, lysis, and loosening according to DeLee and Charnley zones.
This study is part of a stepwise introduction of a new device to orthopaedic practice, and careful monitoring of implants should be carried out as part of the Beyond Compliance principles. The results of this study will provide functional, radiological, and survival data to either support the ongoing use of the HA acetabulum or highlight potential limitations of this new implant before wide adoption.
本研究的主要目的是评估非骨水泥型羟基磷灰石（HA）涂层的Trident II髋臼组件在使用骨水泥型Exeter股骨柄的混合全髋关节置换术（THA）中的生存率。次要目的是评估髋臼组件的并发症、关节特定功能、健康相关生活质量以及松动的放射学征象。
将对125枚植入物进行单中心前瞻性队列研究。招募在研究中心接受混合THA的患者。纳入标准为适合使用非骨水泥髋臼组件、年龄在18至75岁之间、愿意并能够遵守研究方案且能提供知情同意书的患者。排除标准包括不符合研究纳入标准的患者、骨量不足以支持假体固定的患者、BMI>40kg/m²的患者或因严重活动受限而进行THA以缓解疼痛的患者。
将在初次THA后的十年内（1年、2年、5年、7年和10年）进行植入物生存率、并发症、功能结果和放射学评估。功能评估将包括牛津髋关节评分、遗忘关节评分、12项简短健康调查问卷、欧洲五维健康问卷以及疼痛和患者满意度。放射学评估将根据DeLee和Charnley分区评估髋臼透亮线、骨质溶解和松动情况。
本研究是向骨科实践逐步引入新器械的一部分，应按照超越合规原则对植入物进行仔细监测。本研究结果将提供功能、放射学和生存率数据，以支持HA髋臼的持续使用或在广泛应用之前突出这种新植入物的潜在局限性。
