Analysis of Clinical Outcome and Implant Migration of the Cementless Tri-Fit Total Hip Replacement System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Corin
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Femoral Stem Migration Radiographic Assessment
研究概览
简要总结
The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over the course of the study. The study will also record clinical data on each patient using various functional tests and questionnaires at the same intervals.
详细描述
The present study will prospectively recruit 100 patients scheduled for elective total hip replacement with Corin's TriFIT Hip System at the Ottawa Hospital - General Campus. As part of their clinical care, patients routinely undergo a clinical examination and have had radiographs taken at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery. Using specialized software, radiographs from each interval will be examined to assess femoral stem migration and joint wear patterns. Femoral stem migration will be assessed using computer-assisted software. The study will also assess the rate of implant failure during the first two post-operative years. Clinical assessments and questionnaires will also be completed during each of the follow-up intervals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for primary, unilateral total hip replacement (THR) with no previous history of hip replacement and/or fracture surgery.
- •Patients with arthritis secondary Noninflammatory Degenerative Joint Diseases (NIDJD), including osteo/degenerative arthritis, congenital hip dysplasia, and avascular necrosis.
- •Patients who do not meet any of the exclusion criteria.
排除标准
- •Patients with previous fusions, acute femoral neck fractures, above knee amputations, or previous total knee replacement.
- •Patients who had previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device.
- •Patients with neuropathic joints.
- •Patients who required structural bone grafts.
- •Patients with an ipsilateral girdlestone.
- •Patients who otherwise met the study criteria, but for which appropriate clinical follow-up data is not available (i.e. patients deceased prior to 2-year follow-up, patients refused to return for follow-up).
结局指标
主要结局
Femoral Stem Migration Radiographic Assessment
时间窗: 2 weeks to end of study (approximately 2 years) post-operatively
Femoral stem migration (in millimeters (mm)) will be assessed using computer-assisted Einzel Bild Roentgen Analyze-Femoral Component Analysis (EBRA-FCA) software and radiographs taken at each interval.
Radiographic Assessment of Wear in the Acetabular Components
时间窗: 2 weeks to end of study (approximately 2 years) post-operatively
Anterior-posterior (AP) and lateral radiographs from each follow-up visit will be used to assess wear of the acetabular (hip) components.
Rate of Implant Failure
时间窗: 2 weeks to end of study (approximately 2 years) post-operatively
The number of revisions will be recorded.
次要结局
- Harris Hip Score (HHS)(2 weeks to end of study (approximately 2 years) post-operatively)
- UCLA (University of California, Los Angeles) Activity Level(2 weeks to end of study (approximately 2 years) post-operatively)
- SF (Short Form)-12 Questionnaire(2 weeks to end of study (approximately 2 years) post-operatively)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(2 weeks to end of study (approximately 2 years) post-operatively)