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青少年特发性脊柱侧弯非融合手术的配对比较:后路动力撑开装置与椎体牵张术

Matched comparison of non-fusion surgeries for adolescent idiopathic scoliosis: posterior dynamic distraction device and vertebral body tethering.

作者信息

Todderud Julia, Larson A Noelle, Haft Geoffrey, El-Hawary Ron, Price Nigel, Anderson John T, Fitzgerald Ryan, Chan Gilbert, Lonner Baron, Albert Michael, Hoernschemeyer Daniel, Milbrandt Todd A

机构信息

Mayo Clinic Department of Orthopedic Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.

Orthopedic Surgery Artificial Intelligence Laboratory, Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.

出版信息

Spine Deform. 2025 Jan;13(1):135-143. doi: 10.1007/s43390-024-00982-0. Epub 2024 Oct 8.

Abstract

PURPOSE

Two non-fusion devices for adolescent idiopathic scoliosis (AIS) received HDE approval for clinical use in 2019: posterior dynamic distraction device (PDDD) and vertebral body tethering system (VBT). Although indications are similar, there is no comparative study of these devices. We hypothesize that curve correction will be comparable, but PDDD will have better perioperative metrics.

METHODS

AIS PDDD patients were prospectively enrolled in this matched multicenter study. Inclusion criteria were Lenke 1 or 5 curves, preoperative curves 35°-60°, correction to ≤30° on bending radiographs, and kyphosis <55°. Patients were matched by age, sex, Risser, curve type and curve magnitude to a single-center cohort of VBT patients. Results were compared at 2 years.

RESULTS

20 PDDD patients were matched to 20 VBT patients. Blood loss was higher in the VBT cohort (88 vs. 36 ml, p < 0.001). Operative time and postoperative length of stay were longer in the VBT cohort, 177 vs. 115 min (p < 0.001) (2.9 vs. 1.2 days, p < 0.001). Postoperative curve measurement and correction at 6 months were better in the PDDD cohort (15° vs. 24°, p < 0.001; 68% vs. 50%, p < 0.001). At 1-year, PDDD patients had improved Cobb angles (14° vs. 21°, p = 0.001). At 2 years, a correction was improved in the PDDD cohort, with a curve measurement of 17° for PDDD and 22° for VBT (p = 0.043). At the latest follow-up, 3 PDDD patients and 1 VBT patient underwent revision surgery.

CONCLUSION

Early results show PDDD demonstrates better index correction, reduced operative time, less blood loss, and shorter length of stay but higher rates of revision compared to a matched cohort of VBT patients at two-year follow-up.

LEVEL OF EVIDENCE

Level II, prospective cohort matched comparative study.

摘要

目的

两种用于青少年特发性脊柱侧凸(AIS)的非融合器械于2019年获得了用于临床的人类器械豁免(HDE)批准:后路动力撑开装置(PDDD)和椎体拴系系统(VBT)。尽管适应证相似,但尚无对这些器械的比较研究。我们假设两者的曲线矫正效果相当,但PDDD的围手术期指标会更好。

方法

AIS的PDDD患者被前瞻性纳入这项匹配的多中心研究。纳入标准为Lenke 1型或5型曲线、术前曲线35°-60°、在弯曲位X线片上矫正至≤30°以及后凸<55°。患者按年龄、性别、Risser征、曲线类型和曲线严重程度与一个VBT患者的单中心队列进行匹配。在2年时比较结果。

结果

20例PDDD患者与20例VBT患者相匹配。VBT队列的失血量更高(88 vs. 36 ml,p < 0.001)。VBT队列的手术时间和术后住院时间更长,分别为177 vs. 115分钟(p < 0.001)(2.9 vs. 1.2天,p < 0.001)。PDDD队列术后6个月的曲线测量和矫正效果更好(15° vs. 24°,p < 0.001;68% vs. 50%,p < 0.001)。在1年时,PDDD患者的Cobb角有所改善(14° vs. 21°,p = 0.001)。在2年时,PDDD队列的矫正效果有所改善,PDDD的曲线测量值为17°,VBT为22°(p = 0.043)。在最近一次随访时,3例PDDD患者和1例VBT患者接受了翻修手术。

结论

早期结果显示,与匹配的VBT患者队列相比,PDDD在2年随访时表现出更好的初始矫正效果、更短的手术时间、更少的失血量和更短的住院时间,但翻修率更高。

证据级别

二级,前瞻性队列匹配比较研究。

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