A PROSPECTIVE MULTI CENTER RANDOMIZED CONTROLLED TRIAL TO EVALUATE G7 Acetabular System With CoC ARTICULATION COMPARED TO EXCEED ABT Acetabular System With CoC ARTICULATION IN TOTAL HIP ARTHROPLASTY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- the safety and effectiveness of patients (Harris Hip Score)
研究概览
简要总结
Evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Ceramic on Ceramic articulation and Taperloc Complete Microplasty stem compared to patients who received the Exceed ABT Acetabular system with the same combination
详细描述
This study will be a multi-center randomized controlled study. Eligible patients will be randomly assigned to receive a combination of G7 Acetabular system with CoC articulation and Taperloc Complete Microplasty stem or Exceed ABT Acetabular system with CoC articulation and Taperloc Complete Microplasty stem. Patient demographics, preoperative clinical outcomes, operative information, postoperative clinical outcome, radiographic assessment, incidence of squeaking, incidence of dislocation, implant survivorship and adverse events will be collected prospectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
- •Rheumatoid arthritis.
- •Correction of functional deformity.
- •Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- •Revision of previously failed total hip arthroplasty.
- •age over 20 years old
排除标准
- •uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- •osteoporosis,
- •metabolic disorders which may impair bone formation,
- •osteomalacia,
- •distant foci of infections which may spread to the implant site,
- •rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
- •vascular insufficiency, muscular atrophy, or neuromuscular disease.
研究组 & 干预措施
Hip implant1
The Biomet G7 Acetabular System is a modular acetabular system, offering two types of acetabular shells. The shells are available in either a solid shell design, with an apical plug, or a limited hole with an apical plug and optional screw holes. Components are available in numerous designs and sizes intended for both primary and/or revision applications.
干预措施: G7 (Device)
Hip implant2
The Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG).
干预措施: Exceed ABT (Device)
结局指标
主要结局
the safety and effectiveness of patients (Harris Hip Score)
时间窗: 1 year
Harris Hip Score
次要结局
- Gruen zone analysis(Immediate post-op, 6 months, 1 year, 2 year)
- Loosening on its implant(Immediate post-op, 6 months, 1 year, 2 year)
- Dislocation(6 months, 1 year, 2 year)
- Squeaking sounds(6 months, 1 year, 2 year)