Long-term Evolution of Patients Suffering From Lumbar Canal Stenosis and Supported by Minimally Invasive Surgery: SUIVISTENO (SUIVISTENO)
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|ClinicalTrials.gov Identifier: NCT04124146|
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 17, 2019
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.
|Condition or disease||Intervention/treatment|
|Lumbar Spinal Stenosis||Radiation: MRI for some patients according functionnal tests results|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Long-term Evolution of Patients Suffering From Lumbar Canal Stenosis and Supported by Minimally Invasive Surgery|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2021|
Patients with Surgery more than 10 years
Patients with surgery for spinal lumbar stenosis between 2006 and 2008 will be purposed to participate to the study.
Radiation: MRI for some patients according functionnal tests results
Depending on the results obtained on the evaluation criteria, additional examinations could be prescribed (imaging) for subjects with an unsatisfactory functional score. There is therefore a potential change in the usual care.
- sub-functional score [ Time Frame: Month 1 ]items VIII to XII of the Swiss Spinal Stenosis questionnaire (French version).
- Swiss Spinal Stenosis questionnaire (French version) [ Time Frame: Month 1 ]under scores symptoms and satisfaction of the Swiss Spinal Stenosis questionnaire (French version)
- EQ5D questionnaire [ Time Frame: Month 1 ]under scores satisfaction of the EQ5D questionnaire
- Scale of assessment of lower back pain, leg and when walking [ Time Frame: Month 1 ]VAS scale scores
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124146
|Contact: Laura Lecuyer||+33 7 61 83 70 email@example.com|