微创机器人引导与透视引导脊柱融合术的并发症和翻修率：MIS ReFRESH 前瞻性比较研究。
Complications and Revision Rates in Minimally Invasive Robotic-Guided Versus Fluoroscopic-Guided Spinal Fusions: The MIS ReFRESH Prospective Comparative Study.
机构信息
Virginia Spine Institute, Reston, VA.
National Spine Health Foundation, Reston, VA.
出版信息
Spine (Phila Pa 1976). 2021 Dec 1;46(23):1661-1668. doi: 10.1097/BRS.0000000000004048.
STUDY DESIGN
Prospective, multicenter, partially randomized.
OBJECTIVE
Assess rates of complications, revision surgery, and radiation between Mazor robotic-guidance (RG) and fluoro-guidance (FG).
SUMMARY OF BACKGROUND DATA
Minimally invasive surgery MIS ReFRESH is the first study designed to compare RG and FG techniques in adult minimally invasive surgery (MIS) lumbar fusions.
METHODS
Primary endpoints were analyzed at 1 year follow-up. Analysis of variables through Cox logistic regression and a Kaplan-Meier Survival Curve of surgical complications.
RESULTS
Nine sites enrolled 485 patients: 374 (RG arm) and 111 (FG arm). 93.2% of patients had more than 1 year f/u. There were no differences for sex, Charlson Comorbidity Index, diabetes, or tumor. Mean age of RG patients was 59.0 versus 62.5 for FG (P = 0.009) and body mass index (BMI) was 31.2 versus 28.1 (P< 0.001). Percentage of smokers was almost double in the RG (15.2% vs. 7.2%, P = 0.029). Surgical time was similar (skin-to-skin time/no. of screws) at 24.9 minutes RG and 22.9 FG (P = 0.550). Fluoroscopy during surgery/no. of screws was 15.5 seconds RG versus 35.4 seconds FG, (15 seconds average reduction). Fluoroscopy time during instrumentation/no. of screws was 3.6 seconds RG versus 17.8 seconds FG showing an 80% average reduction of fluoro time/screw in RG (P < 0.001). Within 1 year follow-up, there were 39 (10.4%) surgical complications RG versus 39 (35.1%) FG, and 8 (2.1%) revisions RG versus 7 (6.3%) FG. Cox regression analysis including age, sex, BMI, CCI, and no. of screws, demonstrated that the hazard ratio (HR) for complication was 5.8 times higher FG versus RG (95% CI: 3.5-9.6, P < 0.001). HR for revision surgery was 11.0 times higher FG versus RG cases (95% CI 2.9-41.2, P < 0.001).
CONCLUSION
Mazor robotic-guidance was found to have a 5.8 times lower risk of a surgical complication and 11.0 times lower risk for revision surgery. Surgical time was similar between groups and robotic-guidance reduced fluoro time per screw by 80% (approximately 1 min/case).Level of Evidence: 2.
研究设计
前瞻性、多中心、部分随机。
目的
评估 Mazor 机器人制导（RG）和荧光制导（FG）之间并发症、翻修手术和放射的发生率。
背景资料概要
微创外科 MIS ReFRESH 是第一个旨在比较成人微创脊柱融合术 RG 和 FG 技术的研究。
方法
主要终点在 1 年随访时进行分析。通过 Cox 逻辑回归和手术并发症的 Kaplan-Meier 生存曲线分析变量。
结果
9 个站点共招募了 485 名患者：374 名（RG 组）和 111 名（FG 组）。93.2%的患者随访时间超过 1 年。两组在性别、Charlson 合并症指数、糖尿病或肿瘤方面无差异。RG 患者的平均年龄为 59.0 岁，FG 组为 62.5 岁（P=0.009），体重指数（BMI）为 31.2 比 28.1（P<0.001）。RG 组的吸烟者比例几乎是 FG 组的两倍（15.2%比 7.2%，P=0.029）。手术时间（皮肤到皮肤时间/螺钉数量）在 RG 为 24.9 分钟，FG 为 22.9 分钟（P=0.550）。手术过程中的透视时间/螺钉数量在 RG 为 15.5 秒，FG 为 35.4 秒（平均减少 15 秒）。器械插入过程中的透视时间/螺钉数量在 RG 为 3.6 秒，FG 为 17.8 秒，显示 RG 中透视时间/螺钉平均减少 80%（P<0.001）。在 1 年随访期间，RG 组有 39 例（10.4%）手术并发症，FG 组有 39 例（35.1%），RG 组有 8 例（2.1%）翻修，FG 组有 7 例（6.3%）。包括年龄、性别、BMI、CCI 和螺钉数量在内的 Cox 回归分析表明，FG 组并发症的危险比（HR）是 RG 组的 5.8 倍（95%CI：3.5-9.6，P<0.001）。FG 组翻修手术的 HR 是 RG 组的 11.0 倍（95%CI：2.9-41.2，P<0.001）。
结论
Mazor 机器人制导的手术并发症风险降低了 5.8 倍，翻修手术的风险降低了 11.0 倍。两组的手术时间相似，机器人制导使每个螺钉的透视时间减少了 80%（大约 1 分钟/例）。
证据水平
2 级。
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