NCT04918680尚未招募不适用
Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.
详细描述
This study will assess the performance and success rate of the EcoFit Total Hip System. Survivorship and clinical outcomes will help determine implant success 36 months as defined by specific scoring systems and compared to other published data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be a candidate for a total primary hip replacement.
- •Subject must have degenerative joint disease, including osteoarthritis or traumatic arthritis, OR a femoral fracture which can be treated by a primary hip replacement and no other hardware
- •Subject has a BMI of 40.00 kg/m2 or less at the time of enrollment
- •Subject is likely to be available for evaluation for the duration of the study
- •Subject is able and willing to sign the informed consent and follow study procedures
- •Subject is not pregnant
排除标准
- •Subject has had a prior hip replacement in the subject hip
- •Subject has an active cancer or is a survivor for <5 years except for squamous cell or basal cell skin cancer
- •Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol
- •Subject is currently a documented substance abuser (alcohol or other addictions)
- •Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic
- •Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity
- •Subject has a BMI > 40.00 kg/m2
- •Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- •Subject is a prisoner
- •Subject is pregnant
- •Subject has known materials sensitivity (to metals)
结局指标
主要结局
Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery
时间窗: 36 months
Evaluate the overall survivorship of the devices. Observed product-related complications and revisions are recorded and documented.
次要结局
- Evaluate the pre to post-op change in the Harris Hip Score(Pre-op, 6 months, 12 months, 24 months, 36 months)
- Evaluate the pre to post-op change in the WOMAC Score(Pre-op, 6 months, 12 months, 24 months, 36 months)
- Device related complications(Through completion of study, an average of 3.5 years)
研究者
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