Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- five-year wear thickness of the two friction pairs
研究概览
简要总结
Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.
详细描述
A single-centre, prospective, randomised, single-blind, comparative study of two parallel groups of patients undergoing total hip arthroplasty:
- Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
- Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 to 65 years,
- •Who have signed their consent to participate in the study,
- •For whom an indication for total hip arthroplasty has been given
排除标准
- •History of hip surgery
- •Indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly)
- •Hip dysplasia
- •Inflammatory rheumatic disease or any other progressive concomitant condition that may impact the patient's vital or functional prognosis
- •Sequelae of neurological disease or stroke
- •Pregnant or breastfeeding women
- •Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
- •Patient likely not to return for follow-up visits
- •Patient already included in another therapeutic study protocol
- •Patient under court protection, guardianship or curatorship.
结局指标
主要结局
five-year wear thickness of the two friction pairs
时间窗: Year 5
The primary endpoint is the five-year wear thickness of the two friction pairs (CoPXE versus CoC) after total hip arthroplasty. Wear thickness is the measurement of the penetration of the femoral head into the acetabular component. This measurement will be performed on frontal pelvic radiographs centred on the pubic symphysis using the semi-automatic computer-assisted technique described by Martell
次要结局
未报告次要终点