A Follow-Up Study of Subjects Enrolled in the Pin-Based (IDE G920035) and Pinless (IDE G000071) ROBODOC® Surgical System Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Presence of Osteolysis
研究概览
简要总结
This is a follow-up study looking at the and long-term results of two methods of preparing the thigh bone to receive an implant during hip replacement surgery. For one group of patients in the original study, the surgeon used a cutting tool called a broach and a special hammer on patients who had standard hip replacement operations. For the other patients, the surgeon used a surgical robot which was equipped with a cutting tool, like a drill, to prepare the thigh bone. The purpose of this study is to collect additional information confirming that the surgical robot is safe and effective when used as recommended. Only patients who were enrolled in the original clinical trials are eligible for this study.
详细描述
A. Description This study is a follow-up study looking at mid- and long-term outcomes for participants in the IDE G920035 and IDE G000071 Clinical Trials. The IDE G920035 was a randomized, controlled trial with a 1:1 ROBODOC:control randomization. The IDE G000071 was a randomized, controlled trial with a 3:1 ROBODOC:control randomization.
B. Selection Criteria Only subjects who were originally enrolled in the IDE G920035 and IDE G000071 Clinical Trials are eligible to participate in this study. Subjects selected for this study will have completed a minimum of the 3 month follow-up requirements of the IDE G920035 and IDE G000071 Clinical Trials. Enrolled subjects must be willing to give a relevant medical history, undergo a focused physical examination of their operative hip(s), have an AP and lateral x-ray taken of their operative hip(s) and complete the Harris Hip Score, SF-12, UCLA Activity Score, VAS pain self-assessment, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires.
The study subject may be reimbursed for reasonable travel expenses associated with their participation in the study. All requests for reimbursement must be pre-approved by Curexo Technology Corporation.
C. Data Collection Subjects participating in this study will be asked to visit the study site to undergo a physical examination of their operative hip(s). During this visit, they will be asked to give a relevant medical history, have AP and lateral radiographs taken of their operative hip(s), and complete the Harris Hip Score, SF-12, UCLA Activity Score, VAS pain self-assessment, and WOMAC questionnaires.
If the subject has obtained AP and lateral radiographs within the last year, these can be used instead of requiring them to obtain new radiographs specifically for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects included in this study will have completed the follow-up requirements of the IDE G920035 or the IDE G000071 Clinical Trial;
- •Subjects must be willing to give a relevant medical history, undergo a focused physical examination of their operative hip(s) and have an AP and lateral x-ray taken of their operative hip(s);
- •Subjects must be willing to complete the Harris Hip Score, SF-12, WOMAC, UCLA Activity Score, and VAS pain self-assessment questionnaires; and
- •Subjects must be willing to sign an informed consent document.
排除标准
- •There are no exclusion criteria.
结局指标
主要结局
Presence of Osteolysis
时间窗: 14 months
Presence of osteolysis determined by looking at patient x-rays as described by Gruen et al and Johnson et al.
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: 2 months
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to measure clinical outcome. The WOMAC total score ranges 96 (best) to 0 (worst). The WOMAC pain score ranges 0-20, the stiffness score ranges 0-8, and functional limitation score ranges 0-68.
次要结局
- Health Status Questionnaire-12(2 months)
- Harris Hip Score(2 months)
- UCLA Activity Score(2 months)
- Visual Analog Pain Score(2 months)