NCT00546598终止4 期
DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System PMA Post-approval Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 106
- 试验地点
- 6
- 主要终点
- Survivorship
研究概览
简要总结
This study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System.
详细描述
This two-phased study on hip arthroplasty consists of a clinical follow-up phase and a clinical outcomes phase.
The DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System consists of:
- a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and
- a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature
- •Provide informed consent
- •Sufficient acetabular and femoral bone stock to seat the prosthesis
- •Willing and able to return for follow-up as specified by the study protocol
- •Willing and able to complete the hip outcomes questionnaire and quality of life survey (SF12)
- •Undergo hip replacement due to non-inflammatory joint disease, including osteoarthritis, avascular necrosis, congenital hip dysplasia or post-traumatic arthritis.
排除标准
- •Diagnosis of inflammatory arthritides such as rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus, erythematosis etc.
- •Active infections that may spread to other systems such as osteomyelitis, pyogenic infection of the hip joint overt infection, etc.
- •Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb which impedes evaluation.
- •Poor bone quality (e.g. osteoporosis) such that there is concern about the ability of inadequate bone stock to support the implant.
- •Morbid obesity
- •Involvement in high levels of activity or participation in active sports
- •Involvement in heavy manual labor employment
- •Increased likelihood of falls due to concomitant illnesses or impairment
- •Pregnancy, breast-feeding, a prisoner, mentally incompetent, a known alcohol or drug abuser
- •Diagnosis of metabolic disorders or receiving systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant
- •Known history of conditions that may interfere with the total hip arthroplasty survival or outcome (e.g. Paget's disease, Charcot's disease)
- •Known presence of active metastatic or neoplastic disease
- •Known allergic reactions to implant materials (e.g. ceramic, metal)
- •Known history of tissue reactions to implant corrosion or implant wear debris
- •Disabilities of other joints that impedes evaluation (e.g. knees, ankles)
- •Known presence of highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis etc.)
- •Previous prosthetic hip replacement device (any type including THA, surface replacement arthroplasty, endoprosthesis etc.)
研究组 & 干预措施
Duraloc Option COC Hip
Other
干预措施: Total hip replacement/arthroplasty (Device)
结局指标
主要结局
Survivorship
时间窗: 5 years
次要结局
- Study subject SF-12 health survey(1, 2 ,3, 4 and 5 years)
- SF-12 Health survey and Subject Outcomes Questionnaire(6, 7, 8, 9 and 10 years)
- Hip Function (using Harris Hip Score)(6 weeks, 6 months and 1, 2, 3, 4, and 5 years)
研究者
研究点 (6)
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