NCT05416463尚未招募不适用
A Single-blinded Randomized Control Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty
Grand River Hospital0 个研究点目标入组 190 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 主要终点
- Activities of Daily Living
研究概览
简要总结
This study will assess the clinical and health economic value of an intraoperative navigation system for total hip arthroplasty in one Ontario hospital. The results of this study will be used to generate evidence-based recommendations on the use and funding of the device in public hospitals and inform the development of a provincial healthcare innovation pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving primary THA
- •Elective THA
- •Provision of informed consent
排除标准
- •Unable to obtain informed consent
- •Receiving revision THA
- •THA is to treat trauma (i.e. hip fracture and/or dislocation)
- •Patient is undergoing simultaneous bilateral hip replacement
- •Performing surgeon is not participating in the study
- •Hip fracture
- •Hip dislocation
- •Severe osteoporosis
- •Trochanteric osteotomy
- •Suspected or actual infection
- •Existing implanted hardware
- •Severe deformities of the femoral or pelvic bone
- •High Body Mass Index (BMI)*
结局指标
主要结局
Activities of Daily Living
时间窗: up to 12 months
Hip disability and Osteoarthritis Outcome Score (HOOS) Scores are 1-100 and each subscale is scored and then connected with a line on a graph to generate a "HOOS profile". "0 indicates extreme problems and 100 indicates no problems."
次要结局
未报告次要终点
研究者
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