A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Does the Trident II Cup achieve acceptable fixation to the underlying bone?
研究概览
简要总结
The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Trident II Acetabular Cup.
详细描述
The proposed study is a prospective evaluation of data from patients undergoing primary total hip arthroplasty using the Trident II acetabular cup. Fifty patients will be recruited for this study. All patients that qualify for the study per the inclusion-exclusion criteria and provide written informed consent will receive the Trident II acetabular cup and RSA beads. Implant stability, through RSA, will be measured throughout the first two postoperative (post-op) years per the following schedule: immediate post-op and 6 weeks, 3 months, 6 months, 1 year, and 2 years following surgery. Patients will be discharged and seen for follow-up assessments as per standard of care. Adverse events that are related to the index joint will be collected. Health outcome questionnaires will be collected. The health outcome questionnaires will include: EQ-5D, HOOS JR and Harris Hip Score. Health outcome questionnaires will be completed pre-operatively and again at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery. Conventional x-ray analysis will be performed pre-operatively and again at 6 weeks, 1 year and 2 years following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic arthritis of the hip indicating surgical intervention
- •Scheduled to undergo a primary total hip arthroplasty
- •Patient is a candidate for the Trident II acetabular cup in accordance with product labeling -
排除标准
- •Patients less than 18 years of age, or older than 85 years of age.
- •Severe hip dysplasia (Crowe Type III or IV) in the affected hip
- •History of congenital dislocation
- •Prior arthroplasty of the affected hip
- •Active or prior infection of the affected hip
- •Morbid obesity (BMI > 40)
- •Medical condition precluding major surgery
- •Severe osteoporosis
- •Neuromuscular impairment
- •Patients with known allergy to metals
- •Patients on dialysis or creatinine > 2.0
- •Patient is immuno-suppressed -
结局指标
主要结局
Does the Trident II Cup achieve acceptable fixation to the underlying bone?
时间窗: 3 years
The Trident II Cup proximal migration will be assessed. Migration of less than 0.2mm at 2 years and without continuous migration between post-operative year 1 and 2 will indicate acceptable fixation.
次要结局
- What are the migration patterns of the Trident II acetabular cup over the first two post-operative years?(3 years)
- Is there a correlation between radiolucent lines measured by Charnley-DeLee zone analysis and migration characteristics using RSA?(3 years)
- Can inducible displacements measured at 1 year post-operative distinguish patients identified by RSA measurements as having inadequate fixation?(2 years)
- Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?(3 years)