A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 5
- 主要终点
- Incidence of revisions and removals
研究概览
简要总结
The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene
详细描述
Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patients by mail. The follow-up will be annually and only survivorship data will be collected.
This data collection project was developed in order to determine the actual long-term (10-year) survival rate of Biomet's ArCom XL highly cross-linked polyethylene. Data will be collated for uncemented cases only. This will eliminate the possibility of cement or cement debris being a confounding variable.
The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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 fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- •Revision of previously failed total hip arthroplasty
- •Uncemented applications
排除标准
- •Absolute contraindications
- •Infection, sepsis and osteomyelitis
- •Relative contraindications
- •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 be spread to the implant site
- •Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy or neuromuscular disease
结局指标
主要结局
Incidence of revisions and removals
时间窗: Annually through 10 years
Patient questionnaire
次要结局
未报告次要终点