Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 206
- 试验地点
- 6
- 主要终点
- Implant Survival
研究概览
简要总结
The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative.
详细描述
Primary objective
The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative.
Secondary Objectives
Safety will be evaluated by monitoring the frequency and incidence of adverse events over time to 10 years postoperative.
Clinical, functional, radiographic, and quality of life outcomes will be assessed over time to 7 years postoperative. Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form. Radiographs will be reviewed to assess alignment, radiolucencies and other radiographic parameters. Health status and functional ability will be measured using the EQ-5D-3L and the UCLA Activity score.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible for this trial if they satisfy all of the following criteria:
- •Patient is 18 to 65 years of age, inclusive
- •Patient is skeletally mature
- •Patient qualifies for primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history including at least one of the following:
- •Osteoarthritis
- •Avascular necrosis
- •Rheumatoid arthritis
- •Correction of functional deformity
- •Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- •Patient has no history of previous total hip arthroplasty or arthrodesis of the affected hip joint(s)
- •Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent
- •Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB- approved informed consent
排除标准
- •Subjects will be excluded from this trial if they satisfy any of the following criteria as determined by the research staff or in the judgment of the treating physician:
- •Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc.) in the affected hip joint(s)
- •Patient is septic or has an active infection
- •Patient is uncooperative patient or is incapable of following directions
- •Patient is diagnosed with osteoporosis
- •Patient is diagnosed with a metabolic disorder which may impair bone formation
- •Patient is diagnosed with osteomalacia
- •Patient has distant foci of infections which may spread to the implant site
结局指标
主要结局
Implant Survival
时间窗: 5 years postoperatively / Life of Study
The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative.
次要结局
- Radiographic Outcomes(7 Years Post-Operative)
- Clinical Outcomes(7 Years Post-Operative.)
- Functional Outcomes(7 Years Post-Operative)
- Quality of Life Outcomes(7 Years Post-Operative)
- Safety Outcomes(10 Years Post-Operative)