ROBOTICSS - Robotic-Assisted Pedicle Screw Placement in Spine Surgery: A Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7,200
- 试验地点
- 9
- 主要终点
- Proportion of patients in which at least one pedicle screw is not accurately placed (substudy 1)
研究概览
简要总结
This prospective multicenter observational cohort study evaluates robotic-assisted pedicle screw placement compared with non-robotic-assisted techniques in spinal surgery. Primary objectives include screw placement accuracy, operative learning curve, and reoperation rate within 2 years.
详细描述
Pedicle screw fixation is widely used in spinal surgery. Screw misplacement may cause complications and reoperations. Robotic-assisted systems aim to improve accuracy and workflow; however, high-quality real-world evidence regarding long-term clinical outcomes and cost-effectiveness remains limited.
This nationwide cohort study includes consecutive patients undergoing spinal surgery with pedicle screws. Exposure is robotic-assisted versus non-robotic-assisted (navigation-assisted or freehand) screw placement. Data capture is made from registries, radiographs and hospital data. Follow-up is up to 2 years for the primary outcomes and up to 5 years for the secondary outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment with pedicle screws in the cervical, thoracic, lumbar spine and/or sacrum.
- •All ages and spinal diagnoses
排除标准
- •Treatment without pedicle screws
研究组 & 干预措施
Robotic-assisted pedicle screw placement
Robotic-assisted pedicle screw placement using commercially available robotic systems
干预措施: Robotic-assisted pedicle screw placement (Device)
Conventional pedicle screw placement
Conventional pedicle screw placement using navigation-assisted or freehand techniques
结局指标
主要结局
Proportion of patients in which at least one pedicle screw is not accurately placed (substudy 1)
时间窗: Periprocedural
Accurate screw placement is defined as a pedicle screw that remains entirely within the cortical boundary of the pedicle, or with up to 2 mm breach of the pedicle wall (corresponds to Gertzbein-Robbins Grade A and B), assessed on a computed tomography. To evaluate screw placement accuracy, we will define a binary per-patient outcome: whether at least one screw is not accurately placed. The planned sample size for this substudy is 75 patients in the robotic-assisted surgery group, and 426 patients in the non-robotic-assisted group, for a total of 501 patients. For this outcome, previously treated cases may be included as specified in the approved protocol.
Learning curve (substudy 2)
时间窗: Periprocedural
To evaluate the learning curve associated with robotic-assisted surgery, we will model operative time as a function of case number. Operative time is expected to decrease with experience, then plateau. We will use mixed-effects piece-wise linear regression with the surgeon as a random effect to estimate the case number at which operative time levels off. The sample size in this substudy is 100 robotic-assisted spine surgeries in each of the 3 centers currently using robotic-assisted spine surgery (Umeå, Örebro, Uppsala), in total 300 surgeries. For this outcome, previously treated cases may be included as specified in the approved protocol.
Reoperation rate at 2 years (substudy 3)
时间窗: From enrolment up until 2 years after surgery
The primary outcome is the occurrence of reoperations of any cause within 2 years from the index surgery. The expected reoperation rate in the non-robotic group is likely to be higher than 3-5% over a 2-year period, and may in the robotic-assisted group be 1% or less. A difference of 2 percentage points or greater is considered clinically meaningful. Power analyses (80% power, alpha 0.05) have been made in two scenarios, with reoperation rates of 3% vs 1%, or 5% vs 3%. We estimate a ratio of 1:6 for robotic-assisted surgery vs navigation-assisted or free hand surgeries. Comparing 3% and 1% reoperation rates, 420 robotic-assisted surgery patients and 2,520 non-robotic surgery patients are needed (yielding a total sample size of 2,940 patients). In case reoperation rates are 5% and 3%, 866 robotic-assisted surgery patients and 5,196 non-robotic surgery patients are needed (yielding a total sample size of 6,062 patients).
次要结局
- Health economic analysis(From enrollment until the two-year follow-up)
- Screw placement precision(Periprocedural)
- Length of stay(Periprocedural)
- Time to return to work(From surgery until 2 years after surgery)
- EQ-VAS(At the one-year follow-up)
- EQ-5D(At the one-year follow-up)
- Proportion of patients achieving the patient acceptable symptom state (PASS) for EQ-VAS(At the one-year follow-up)
- Adverse events- thromboembolic and cardiovascular complications(From enrolment until the 2 year follow-up)
- Adverse events- mortality(From enrolment until the 2 year follow-up)