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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
Sponsor:
Information provided by (Responsible Party):
Centre Medico-Chirurgicale et Obstetrique Cote d'Opale

Brief Summary:

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

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. sub-functional score [ Time Frame: Month 1 ]
    items VIII to XII of the Swiss Spinal Stenosis questionnaire (French version).


Secondary Outcome Measures :
  1. Swiss Spinal Stenosis questionnaire (French version) [ Time Frame: Month 1 ]
    under scores symptoms and satisfaction of the Swiss Spinal Stenosis questionnaire (French version)

  2. EQ5D questionnaire [ Time Frame: Month 1 ]
    under scores satisfaction of the EQ5D questionnaire

  3. Scale of assessment of lower back pain, leg and when walking [ Time Frame: Month 1 ]
    VAS scale scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been cared for at the institution between 2006 and 2008 (cohort) will be invited to participate in the study.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Laura Lecuyer +33 7 61 83 70 30 llecuyer.clinconsult@gmail.com

Sponsors and Collaborators
Centre Medico-Chirurgicale et Obstetrique Cote d'Opale

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Responsible Party: Centre Medico-Chirurgicale et Obstetrique Cote d'Opale
ClinicalTrials.gov Identifier: NCT04124146     History of Changes
Other Study ID Numbers: SUIVISTENO
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The source documents are the original documents, the data and the files, from which the data concerning the research participants are reported in the observation notebook. Excel file that can be opened from a password

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases