A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Range of Motion
研究概览
简要总结
The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty.
详细描述
There are no clinical studies conducted on its performance in Asian population. Furthermore clinical data is required to support marketing and validate design of M2A Magnum.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suitable for primary Total Hip Replacement
- •Patients aged over 20
- •Patients with limited co-morbidity- ASA I-III
- •Patients must be able to understand instructions and be willing to return for follow-up
- •Patients willing to provide blood and urine samples for metal ion analysis at follow-up
排除标准
- •Pre-existing metal implants
- •Infection, sepsis, and osteomyelitis
- •Uncooperative patient or pt 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
- •vascular insufficiency, muscular atrophy, or neuromuscular disease
- •pregnancy
研究组 & 干预措施
M2a Magnum
Total HIp Arthroplasty using with the M2a Magnum Large Metal Articulation is an ultra-high performance metal-on-metal articulation with a big ball (greater than or equal to 38mm) in acetabulums as small as 44mm.
干预措施: Total Hip Arthroplasty (Device)
M2a Taper
Total Hip Arthroplasty using with the M2a Taper Acetabular System consists of a titanium outer shell with cobalt chromium (Co-Cr-Mo) metallic liner, which articulates with with a cobalt chromium (Co-Cr-Mo) modular femoral head.
干预措施: Total Hip Arthroplasty (Device)
结局指标
主要结局
Range of Motion
时间窗: 1 year
Hip Flexion Angle at 1 year postoperatively
次要结局
- Metal Ion(5 year)
- UCLA Activity Score(5 year)
- Radiographic Assessment(5 year)
- Harris Hip Score(5 year)