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临床试验/NCT05953792
NCT05953792已完成不适用

Selecting the Vertebra Above Sagittal Stable Vertebra as the Distal Fusion Level in Scheuermann's Kyphosis

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Sagittal vertical axis (SVA) in millimeters

研究概览

简要总结

The proper selection of the lowest instrumented vertebra (LIV) remains controversial in the surgical treatment of Scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (SSV-1) as LIV. The purpose of this study is to investigate whether SSV-1 could be a valid LIV for Scheuermann kyphosis (SK) patients with different curve patterns.

详细描述

The proper selection of the lowest instrumented vertebra (LIV) remains controversial in the surgical treatment of Scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (SSV-1) as LIV. The purpose of this study is to investigate whether SSV-1 could be a valid LIV for Scheuermann kyphosis (SK) patients with different curve patterns.

This was a prospective study on consecutive SK patients treated with posterior surgery between January 2018 and September 2020, in which the distal fusion level ended at SSV-1. The LIV was selected at SSV-1 only in patients with Risser > 2 and with LIV translation less than 40mm. All of the patients had a minimum of 2-year follow-up. Patients were further grouped based on the sagittal curve pattern as thoracic kyphosis (TK) and thoracolumbar kyphosis (TLK). Radiographic parameters including global kyphosis (GK), lumbar lordosis (LL), sagittal vertical axis (SVA), LIV translation, pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS) were measured preoperatively, postoperatively and at the latest follow-up. The intraoperative and postoperative complications were recorded. The Scoliosis Research Society (SRS)-22 scores were performed to evaluate clinical outcomes.

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
10 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of SK patients;
  • underwent one-stage posterior spinal fusion (PSF) with multi-level Ponte osteotomies;
  • selecting SSV-1 as LIV;
  • with a minimum follow-up of 2 years.

排除标准

  • with previous spinal surgical history;
  • with any other spinal deformities;
  • without complete follow-up data.

结局指标

主要结局

Sagittal vertical axis (SVA) in millimeters

时间窗: 24 months

Measured on anteroposterior and lateral radiographs and defined as the horizontal distance between C7PL and the posterior superior corner of sacrum.

Global kyphosis (GK) in degrees

时间窗: 24 months

Measured on anteroposterior and lateral radiographs and defined as the angle from upper to lower most tilted end vertebrae.

Lumbar lordosis (LL) in degrees

时间窗: 24 months

Measured on anteroposterior and lateral radiographs and defined as the angle between the the superior end plate of L1 and S1

次要结局

  • Rates of distal junctional kyphosis(24 months)
  • Scoliosis Research Society (SRS)-22 questionnaire(24 months)

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

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