A Prospective Study to Define Optimum Cup Orientation in Hip Arthroplasty Accounting for the Individual's Anatomy and Movement Patterns
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Cup Orientation
研究概览
简要总结
The purpose of this study is to investigate and determine the optimal zone for implanting the cup component (the ball that sits in the joint socket) in a total hip replacement. Enrolled participants will have a series of X-rays analyzed before surgery to identify their individual optimal zone or cup orientation. This information will be provided to the operating surgeon, who may use this information to influence the placement of the cup implant. Follow-up X-rays taken after surgery will determine if the cup is within the suggested optimal zone. Questionnaires will be completed before and after surgery, and data on complications or issues with the surgery (including incidents of dislocation) will be collected after 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
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed up for primary total hip arthroplasty procedures at the General Campus at The Ottawa Hospital.
排除标准
- •Unwilling or unable to complete study requirements (either X-rays or questionnaires)
- •Unwilling or unable to sign the informed consent form
研究组 & 干预措施
Optimum Cup Orientation
干预措施: Optimum Cup Orientation (Procedure)
结局指标
主要结局
Cup Orientation
时间窗: 12 months after surgery
The degree of cup inclination and anteversion as shown on X-rays
次要结局
- Change in Patient Reported Health(12 months)
- Change in Patient Reported Function(12 months)
- Change in Patient Reported Pain(12 months)
- Incidence of Adverse Events(Up to 12 months after surgery)