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
- 2
- 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
- •Age 18 - 80 years
- •Body mass index ≤40 (BMI = kg/m2)
- •Patient is willing and able to provide informed consent
- •Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis or avascular necrosis of the hip based on Investigator's clinical judgment
- •Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System
排除标准
- •Has undergone an orthopaedic procedure of the spine or lower extremity, or is currently participating in a pain management clinical study of any joint, within the last 6 months or planned within the next 6 months
- •Patients receiving simultaneous bilateral hip arthroplasties are excluded from participation in this study; as well as any participants with staged bilateral arthroplasties within 6 months of each other
- •Active infection, sepsis, osteomyelitis
- •Patient is at a high risk for dislocation including those with long-segment spinal fusions (>3 levels) and neuromuscular disorders
- •Inflammatory (rheumatoid or psoriatic arthritis) or post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis
- •Would, in the Investigator's opinion, be unwilling or unable to comply with the postoperative follow-up schedule
- •Patient is considered a member of a vulnerable population (pregnant, prisoner, mentally incompetent, etc.)
- •Previous hardware in the proximal femur or acetabulum from a prior orthopaedic procedure
研究组 & 干预措施
Robotic-Assisted THA
Consecutive participants will receive THA via the ROSA Hip System.
干预措施: One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric System (Device)
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
- Physician Radiographic Assessment of Significant Radiographic Findings(2 Years)
- 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)