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

NCT ID: NCT04124146

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-05-01

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.

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.

Conditions

Lumbar Spinal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

MRI for some patients according functionnal tests results

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Medico-Chirurgicale et Obstetrique Cote d'Opale

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Laura Lecuyer

Role: CONTACT

llecuyer.clinconsult@gmail.com

+33 7 61 83 70 30

Other Identifiers

SUIVISTENO

Identifier Type: -

Identifier Source: org_study_id