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补品的耐用性。棒构造 - 用于长节段后路器械脊柱融合的补充棒技术

2026年9月30日 更新者：AO Foundation, AO Spine

辅助杆结构的耐久性 - 补充杆技术 (SMART) - 用于长节段后路器械脊柱融合手术：双杆结构的多中心回顾性比较研究

This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This multicenter retrospective comparative cohort study will enroll 1244 patients, who underwent primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. By comparing two groups of patients, ie, patients treated with supplementary rod constructs vs dual-rod constructs, in the setting of long-segment posterior instrumented spinal fusion, this study aims to provide quality evidence regarding the benefits of supplementary rod constructs in reducing the risk of RFs and other mechanical complications. This study shall provide the first long-term clinical evidence on clinical outcome and benefit of supplementary rod constructs.

All participating surgeons will be asked to identify a time point, denoted as X, when they started using predominantly either supplementary rod constructs or dual-rod constructs for long-segment posterior TL instrumented spinal fusion. This time point X must be on or before December 31, 2020 (the last eligible date for the index surgery). Participating surgeons will be instructed to select the time point X to be as early within the collection window as feasible to maximize the available FU period.

Once the time point X is identified for a participating surgeon, medical records of patients treated by this surgeon will be reviewed to identify consecutive eligible patients with the index surgery done between the time point X and December 31, 2020, inclusive. In the case that an eligible patient had undergone several surgeries during this period, the first primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct or a dual-rod construct is defined as the index surgery.

Patients will then be grouped based on the rod constructs into either the supplementary rod construct group or dual-rod construct group.

The study has two FU periods:

  • The first FU period is the first 2 years after the index surgery. The primary analysis will be done using data from the first 2 years of FU.
  • The second FU period ends on December March 31, 20232024. The duration of this FU therefore ranges from 3 years and 3 months to 10 years and 3 months.

The primary study endpoint is the occurrence of the first RF within 2 years after the index surgery.

研究类型

观察性的

注册 (估计的)

1244

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
      • Hong Kong、中国
        • 完全的
        • Duchess of Kent Children's Hospital
  • 加拿大
      • Calgary、加拿大、T2N 2T9
        • 招聘中
        • University of Calgary Spine
        • 接触：
          • Ganesh Swamy
      • Toronto、加拿大、M5T 2S8
        • 招聘中
        • University of Toronto
        • 接触：
          • Stephen Lewis
        • 接触：
          • Christopher Nielsen
  • 印度
  • 土耳其（türkiye）
  • 日本
      • Hamamatsu、日本、431-3192
        • 完全的
        • Hamamatsu University School of Medicine
      • Tokyo、日本、113-8654
        • 招聘中
        • University of Tokyo
        • 接触：
          • So Kato, Prof
  • 美国
    • California
      • Redwood City、California、美国、94588
      • Sacramento、California、美国、95819
      • San Francisco、California、美国、94144
        • 终止
        • UCSF Spine Center
    • Maryland
      • Baltimore、Maryland、美国、21287
        • 招聘中
        • John Hopkis Hospital
        • 接触：
          • Khaled Kebaish
    • Minnesota
      • Minneapolis、Minnesota、美国、55454
        • 招聘中
        • University of Minnesota Medical Center
        • 接触：
    • Missouri
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University in St. Louis, School of Medicine
        • 接触：
          • Brian Neuman
      • St Louis、Missouri、美国、63310
        • 完全的
        • Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110
    • New York
      • New York、New York、美国、10032
        • 招聘中
        • Columbia University / NYP Och Spine Hospital
        • 接触：
          • Zeeshan Sardar
    • Virginia
      • Charlottesville、Virginia、美国、22908
  • 西班牙
      • Barcelona、西班牙、08035
        • 招聘中
        • Hospital Vall d´Hebron
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

45年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients who underwent long-segment posterior thoracolumbar (TL) instrumented fusion

描述

Inclusion Criteria:

  • Age 45 years and older.

  • Patients receiving long-segment posterior TL instrumented fusion using either supplementary rod constructs or dual-rod constructs (the index surgery).

    • Long-segment is defined as the UIV at a thoracic level and the LIV at the sacrum/ilium.
    • Supplementary rod constructs are defined as: in addition to the traditional two primary rods, at least one supplementary rod (eg, accessory rods or satellite rods) is used, and at least one supplementary rod and one primary rod (ie, at least two rods) together must span multiple (≥ 2) vertebral levels. The supplementary rod constructs do not include rods connected end-to-end or side-to-side that do not bridge multiple vertebral levels.
    • The index surgery can be a primary surgery or a revision surgery.
    • The index surgery, staged or non-staged, must use posterior spinal fusion but can be in combination with other approaches such as an anterior procedure.

  • If the index surgery is a revision surgery, the primary rods must be replaced in the revision surgery, with the exception of Harrington or Luque rods which can remain in place.

    o If the Harrington or Luque rods remain in situ, they must already have the UIV at the thoracic level and the LIV at the sacrum/ilium, or an extension of the existing Harrington or Luque is performed such that the UIV is at the thoracic level and the LIV at the sacrum/ilium.

  • The index surgery was performed between January 1, 2014, and December 31, 2020, inclusive.

  • Minimum 3 months of FU after the index surgery.

  • Ability to provide informed consent according to the IRB/EC defined and approved procedures if applicable for retrospective data analysis.

Exclusion Criteria:

  • Spinal fusion performed for acute trauma (ie, ≤ 1 year of trauma).
  • Spinal fusion performed for tumor.
  • Spinal fusion performed for infection.
  • Patients with Parkinson's Disease.
  • Patients with neuromuscular disorders.
  • Patients with spine malignancies requiring chemo- or radiation therapy.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：RETROSPECTIVE

队列和干预

团体/队列
干预/治疗
primary/revision long-segment posterior TL instrumented fusion with dual-rod constructs

The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using dual-rod construct.
程序：long-segment posterior TL instrumented fusion

long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs.
primary/revision long-segment posterior TL instrumented fusion with supplementary rod constructs

The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct.
程序：long-segment posterior TL instrumented fusion

long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Rod fracture (RF)
大体时间：2 years

Incidence of rod fracture(s)
2 years

次要结果测量

结果测量
措施说明
大体时间
Time to rod fracture
大体时间：2 years

Time to the first rod fracture after index surgery
2 years
Time to rod fracture
大体时间：10 years and 3 months

Time to the first rod fracture after index surgery
10 years and 3 months
Configurations of supplementary rod constructs
大体时间：Baseline

Descriptions of configurations of supplementary rod constructs
Baseline
Treatment for rod fracture
大体时间：10 years and 3 months

Descriptions of different treatment strategies for rod fractures
10 years and 3 months
Recurrent RFs
大体时间：10 years and 3 months

Incidence of recurrent rod fractures
10 years and 3 months
Other mechanical failures
大体时间：10 years and 3 months

Other mechanical failures other than rod fractures
10 years and 3 months
Surgical complications
大体时间：10 years and 3 months

Selective surgical complications
10 years and 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AO Foundation, AO Spine

调查人员

  • 首席研究员：Justin S Smith, MD, PhD、Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年3月24日

初级完成 (估计的)

2027年12月15日

研究完成 (估计的)

2029年7月31日

研究注册日期

首次提交

2024年3月20日

首先提交符合 QC 标准的

2024年4月11日

首次发布 (实际的)

2024年4月16日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • SMART

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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