Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): A Longitudinal Cohort Study of the Hydroxyapatite Coated Trident II Acetabular System in Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- NHS Lothian
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Implant survival
研究概览
简要总结
This is a prospective cohort study assessing the survival of a new acetabula component which is based on the original Trident acetabular system (cementless shell) which is used for Total Hip Arthroplasty. The manufacturer recently introduced the evolution of this product, the Trident® II acetabular shell which was launched in 2017. This implant is CE marked and is now widely available for the UK market, however has minimal clinical outcomes data to support its use. As part of a stepwise introduction of devices to orthopaedic practice. This study will report the 10 year implant survival and patient functional outcomes of this new implant.
详细描述
125 patients will be recruited at a single-centre as part of a, phase-4 post-market surveillance, prospective cohort study
This is a 10-year study of the Trident II acetabular component as part of total hip replacement at the Royal Infirmary of Edinburgh, NHS Lothian.
Patients will receive a Trident® II acetabular component as part of primary total hip arthroplasty at the study centre. This component is CE marked and widely available for use by UK surgeons. The Trident® II shells are HA coated, cementless, press-fit acetabular shells composed of a Titanium (Ti-6Al-4V) substrate featuring a CpTi roughened surface with PureFix™ HA. The cup is available in a range of sizes and is indicated for primary and revision procedures.
A standard operative technique will be employed by all study surgeons, using the posterior approach. The routine post-operative patient care protocol of the study centre will be employed.
10 year implant survival is the primary aim, but in addition functional and radiographical outcome will be assessed a 1, 2, 5, 7 and 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing planned primary total hip arthroplasty with standard implants, suitable for the use of the uncemented Trident® II acetabular component.
- •Patients aged 18-75
- •Patients willing and able to comply with the study protocol
- •Patients that provide informed consent
排除标准
- •Patients not meeting study inclusion criteria
- •Bone stock that is inadequate for support or fixation of the prosthesis
- •Patients with a body mass index (kg/m2) >40
- •Procedures performed for pain relief in those with severely restricted mobility
研究组 & 干预措施
Trident® II HA coated shells
Patients will receive a Trident® II acetabular component as part of primary total hip arthroplasty at the study centre. This component is CE marked and widely available for use by UK surgeons. The Trident® II shells are HA coated, cementless, press-fit acetabular shells composed of a Titanium (Ti-6Al-4V) substrate featuring a CpTi roughened surface with PureFix™ HA.
干预措施: Stryker Trident® II HA coated cementless acetabula component (Device)
结局指标
主要结局
Implant survival
时间窗: 10 years
All failures or revision of the Trident® II components as well as liner revisions will be documented.
次要结局
- Hip pain(Preoperative, 1, 2, 5, 7 and 10 years)
- Patient satisfaction(Preoperative, 1, 2, 5, 7 and 10 years)
- Oxford hip score(Preoperative, 1, 2, 5, 7 and 10 years)
- Forgotten Joint Score(Preoperative, 1, 2, 5, 7 and 10 years)
- Radiographic (x-ray) assessment(Preoperatively, 1, 5 and 10 years)
- Short Form 12(Preoperative, 1, 2, 5, 7 and 10 years)
- EuroQol 5-dimension(Preoperative, 1, 2, 5, 7 and 10 years)