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临床试验/NCT04124146
NCT04124146Unknown不适用

Long-term Evolution of Patients Suffering From Lumbar Canal Stenosis and Supported by Minimally Invasive Surgery

Centre Medico-Chirurgicale et Obstetrique Cote d'Opale0 个研究点目标入组 100 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
sub-functional score

研究概览

简要总结

describe the functional evolution of patients at more than 10 years post intervention.

describe the evolution of pain, satisfaction, quality of life of patients to more than 5 years pot intervention.

详细描述

Stenosis of the lumbar canal is a degenerative disorder, occurring most often in the elderly or middle aged, after 50 years. It most often results from the combination of 2 pathologies: the congenital narrowness of the lumbar canal is decompensated over time by the anatomical reorganizations generated by osteoarthritis. It is classically manifested by pain in the lower limbs, occurring almost exclusively in walking or in case of prolonged standing. This postural and dynamic character of the symptomatology is very characteristic of this pathology. The levels most often involved are L4 / L5 and L3 / L4. But, in case of extensive stenosis, other levels may be involved (L2 / L3, L5S1 or even L1 / L2).

Surgical treatment is obviously indicated from the outset in emergency situations or in cases of severe functional disability. It is most often proposed in case of failure of a complete and well-conducted medical treatment. In practice, in cases of tight canal stenosis, only a surgical operation can relieve the patient of pain and recover a normal walk.

A minimal invasive technique: lumbar recalibration, which consists of decompression of the roots of the horse's tail under a microscope without fusion, without arthrodesis, provides a short-term functional benefit, even when Grade 1 spondylisthesis exists. The interest of this technique for the patient is twofold: first aesthetic because the incision is much smaller than in the classical technique and becomes almost invisible after a few months; then and above all it is functional because, by preserving the paravertebral muscles that it allows, this procedure is less painful and allows a lift the same day and an earlier recovery activities.

Very few scientific publications compare different surgical techniques, and even fewer results are available on the long-term future of patients.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients operated within the institution between 2006 and 2008
  • •Major patient (18 years old or over).
  • •Francophone.
  • •Affiliated to a social security scheme

排除标准

  • •Pregnant or lactating women according to article L1121-5 of the CSP.
  • •Vulnerable persons according to article L1121-6 of the CSP.
  • •Major persons placed under guardianship or curatorship

结局指标

主要结局

sub-functional score

时间窗: Month 1

items VIII to XII of the Swiss Spinal Stenosis questionnaire (French version).

次要结局

  • EQ5D questionnaire(Month 1)
  • Swiss Spinal Stenosis questionnaire (French version)(Month 1)
  • Scale of assessment of lower back pain, leg and when walking(Month 1)

研究者

发起方
Centre Medico-Chirurgicale et Obstetrique Cote d'Opale
申办方类型
Network
责任方
Sponsor

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