A Multi-Centre Post Market Clinical Follow-Up Study of MOTIVATION HIP Total Hip System in Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Implant survivorship based on revision rate
研究概览
简要总结
This is a retrospective and prospective, multi-center, post-market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the study device system.
详细描述
The objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available MOTIVATION HIP Total Hip System used in primary total hip arthroplasty (THA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years old, inclusive.
- •Had a primary unilateral or bilateral (simultaneous or staged) THA based on physical exam and medical history, including diagnosis of severe hip pain and disability.
- •Had received MOTIVATION HIPTM Total Hip System per the approved indications for use for the THA.
- •No history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joint(s) beside investigational product.
- •Willing and able to provide written informed consent by signing and dating the EC approved informed consent form.
- •Willing and able to complete scheduled follow-up evaluations..
排除标准
- •The patient is:
- •A prisoner
- •Mentally incompetent or unable to understand what participation in the study entails
- •A known alcohol or drug abuser
- •Anticipated to be non-compliant
- •Has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure or complications in postoperative care.
- •Has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
- •Has a diagnosed systemic disease that could affect his/her safety or the study outcome.
- •Known to be pregnant.
- •Has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
- •Insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e., osteoporosis), cancer, and radiation.
- •Osteoradionecrosis in the affected hip joint.
- •Known sensitivity or allergic reaction to one or more of the implanted materials.
- •Known local bone tumors and/or cysts in the operative hip.
- •Body Mass Index (BMI) > 40.
结局指标
主要结局
Implant survivorship based on revision rate
时间窗: 10 years
Implant survivorship will be assessed using a Kaplan-Meier analysis. Data will be considered right-censored for all subjects that do not have a device related failed. For subjects who are lost-to-follow up, their last available clinical visit will be considered as the censored date. For subjects who died during the study, their death date will be used as the censored date. The survivorship point estimate and 95% confidence interval about the point estimate will be calculated for each follow up visit (1 year, 2 years, 3 years, 5 years, 7 years and 10 years).
次要结局
- Functional outcome based on Harris Hip Score(10 years)
- Safety assessment(10 years)
- Quality of life based on EQ-5D questionnaire(10 years)