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

Lumbar Spinal Stenosis Clinical Trial

— SUIVISTENO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04124146
• Other study ID #: SUIVISTENO
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: October 2019
• Source: Centre Medico-Chirurgicale et Obstetrique Cote d'Opale
• Contact: Laura Lecuyer
• Phone: +33 7 61 83 70 30
• Email: llecuyer.clinconsult[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Medico-Chirurgicale et Obstetrique Cote d'Opale

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sub-functional score	items VIII to XII of the Swiss Spinal Stenosis questionnaire (French version).	Month 1
Secondary	Swiss Spinal Stenosis questionnaire (French version)	under scores symptoms and satisfaction of the Swiss Spinal Stenosis questionnaire (French version)	Month 1
Secondary	EQ5D questionnaire	under scores satisfaction of the EQ5D questionnaire	Month 1
Secondary	Scale of assessment of lower back pain, leg and when walking	VAS scale scores	Month 1