NCT05071144招募中不适用
Advanced SPinal Innovations With Robotics and Enabling Technology Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 11
- 主要终点
- proportion of pedicle screws within 2 mm of cortical breach
研究概览
简要总结
Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of a spine deformity
- •Scheduled for surgery using robotics and navigation and/or patient-specific rods
- •Up to and including 21 years of age
- •Speak and read English or Spanish
排除标准
- 未提供
研究组 & 干预措施
Pediatric Spine Deformity Patients
Standard of care surgery using robotics coupled with navigation and/or patient-specific rods
结局指标
主要结局
proportion of pedicle screws within 2 mm of cortical breach
时间窗: Time of surgery
The proportion of pedicle screws within 2 mm of cortical breach when assessed on intraoperative O-arm scans and postoperative CT scans (when applicable).
次要结局
- Estimated blood loss (EBL)(Time of surgery)
- radiation dose to patient and surgeon per screw(Time of surgery)
- Scoliosis Research Society (SRS-30) Questionnaire(Baseline, 6 Months, 1 Year, 2 Years, and 5 Years)
- Early Onset Scoliosis 24-Item Questionnaire (EOSQ-24)(Baseline, 6 Months, 1 Year, 2 Years, and 5 Years)
- Caregiver Priorities & Child Health Index of Life with Disabilities (CP Child)(Baseline, 6 Months, 1 Year, 2 Years, and 5 Years)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity(Baseline, 6 Months, 1 Year, 2 Years, and 5 Years)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety(Baseline, 6 Months, 1 Year, 2 Years, and 5 Years)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depressive Symptoms(Baseline, 6 Months, 1 Year, 2 Years, and 5 Years)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Mobility(Baseline, 6 Months, 1 Year, 2 Years, and 5 Years)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain - Interference(Baseline, 6 Months, 1 Year, 2 Years, and 5 Years)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships(Baseline, 6 Months, 1 Year, 2 Years, and 5 Years)
- Total operative cost(Time of surgery)
- Improvement to spinopelvic alignment with PSR(Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years)
- Operative time(Time of surgery)
研究者
Daniel Hedequist
Principal Investigator
Boston Children's Hospital
研究点 (11)
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