A Post-Market, Multi-Center, Single Arm Trial on Robotic Instrumentation (ROSA® Hip System) in Patients Undergoing Direct Anterior Total Hip Arthroplasty With Fluoroscopic Guidance
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Accuracy of implant position
研究概览
简要总结
This study is a Prospective, Multicenter, Single-Arm, Cohort post-market study to evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System).
详细描述
Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process.
The primary objective of this study is to assess the accuracy of acetabular implant position by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their intra-operative and/or post-operative full pelvis fluoroscopic or radiographic images show the postoperative acetabular inclination to be within this safe zone range.
Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results, and patient reported outcome measures.
Data collection will occur at the following intervals: Pre-operative, Operative, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Accuracy of implant position
时间窗: 90 days
To evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System) (rTHA). Accuracy of acetabular implant position will be assessed by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their intra-operative and/or post-operative full pelvis fluoroscopic or radiographic images show the postoperative acetabular inclination to be within this safe zone range.
次要结局
- Evaluation of Patient safety(24 months)
- Numeric Pain Rating Scale (NPRS)(24 months)
- Patient Reported Outcome Measure (Oxford Hip Score)(24 months)
- Clinical performance will be assessed with evaluation of stability using the Trendelenburg test.(24 months)
- Subject Satisfaction(24 months)
- Clinical performance will be assessed with evaluation of range of motion.(24 months)
- Clinical performance will be assessed by testing leg length discrepancy.(24 months)
- Physician Radiographic Assessment of Acetabular Cup(2 Years)
- Physician Radiographic Assessment of Femoral and Global Offset and Leg Length Discrepancy(2 Years)
- Physician Radiographic Assessment of Significant Radiographic Findings(2 Years)