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临床试验/NCT04086199
NCT04086199Unknown不适用

Discectomy for Lumbar Active Discopathy: Long Term Functional Outcome Comparison Between Anterior and Posterior Approach: A Retrospective Study

Centre Hospitalier Régional de la Citadelle1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
Modified Macnab Criteria

研究概览

简要总结

The study aims to study the impact on different surgical approaches for lumbar active discopathy. This inflammatory disease of the disc and adjacent vertebral endplates can induce low back pain with inflammatory-like features. Lumbar fusion is proposed to the patient when conservative management is not enough. This fusion can be obtained by an anterior muscle sparring approach or by a posterior muscle decaying approach.

The goal with this single center retrospective study is to identify the surgical approach that offers to the patient the better long term functional outcome. A phone call would allow us to ask patients a few questions:

  • Mcnab's criteria
  • Roland Morris Disability Questionnaire

The patients medical file review would also allow us to identify:

  • the length of hospital stay for the discectomy (in days)
  • incidence of Failed Back Surgery Syndrome
  • incidence of redo surgeries
  • incidence of adjacent level diseases
  • incidence of dural tears and eventual complications (meningitis, orthostatic headaches,...)
  • incidence of iliac vessels injuries and eventual complications (thrombosis, need for revascularisation,...)

详细描述

  1. The Roland-Morris Disability Questionnaire

When your back hurts, you may find it difficult to do some of the things you normally do.

This list contains sentences that people have used to describe themselves when they have back pain. When you read them, you may find that some stand out because they describe you today.

As you read the list, think of yourself today. When you read a sentence that describes you today, put a tick against it. If the sentence does not describe you, then leave the space blank and go on to the next one. Remember, only tick the sentence if you are sure it describes you today.

  1. I stay at home most of the time because of my back.
  2. I change position frequently to try and get my back comfortable.
  3. I walk more slowly than usual because of my back.
  4. Because of my back I am not doing any of the jobs that I usually do around the house.
  5. Because of my back, I use a handrail to get upstairs.
  6. Because of my back, I lie down to rest more often.
  7. Because of my back, I have to hold on to something to get out of an easy chair.
  8. Because of my back, I try to get other people to do things for me.
  9. I get dressed more slowly then usual because of my back.
  10. I only stand for short periods of time because of my back.
  11. Because of my back, I try not to bend or kneel down.
  12. I find it difficult to get out of a chair because of my back.
  13. My back is painful almost all the time.
  14. I find it difficult to turn over in bed because of my back.
  15. My appetite is not very good because of my back pain.
  16. I have trouble putting on my socks (or stockings) because of the pain in my back.
  17. I only walk short distances because of my back.
  18. I sleep less well because of my back.
  19. Because of my back pain, I get dressed with help from someone else.
  20. I sit down for most of the day because of my back.
  21. I avoid heavy jobs around the house because of my back.
  22. Because of my back pain, I am more irritable and bad tempered with people than usual.
  23. Because of my back, I go upstairs more slowly than usual.
  24. I stay in bed most of the time because of my back.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients suffering from lumbar active discopathy (MODIC 1, 2 or 3) with low back pain as dominant symptom and insufficiently relieved by conservative treatments

排除标准

  • Irradiated leg pain as dominant symptom
  • Acquired symptomatic spinal canal stenosis requiring decompression
  • Previous lumbar surgeries

结局指标

主要结局

Modified Macnab Criteria

时间窗: At the time of the phone call, up to 11 years after the surgery

次要结局

  • The Roland-Morris Disability Questionnaire The Roland-Morris Disability Questionnaire The Roland-Morris Disability Questionnaire The Roland-Morris Disability Questionnaire(At the time of the phone call, up to 11 years after the surgery)
  • Complications related to the surgery(From date of surgery (lumbar discectomy) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months)
  • Length of hospital stay for the discectomy surgery(From date of admission in the hospital for the surgery until the date of release from the hospital.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Remacle Thibault

MD, Resident in Neurosurgery Department, PhD Student University Of Liege, Belgium

Centre Hospitalier Régional de la Citadelle

研究点 (1)

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