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

NCT04124146 | Unknown

• 1 other identifier: SUIVISTENO
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• sub-functional score

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

  Month 1

Secondary Outcomes (3)

• Swiss Spinal Stenosis questionnaire (French version)

  Month 1

• EQ5D questionnaire

  Month 1

• Scale of assessment of lower back pain, leg and when walking

  Month 1

Study Arms (1)

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

Interventions

MRI for some patients according functionnal tests results 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.

Patients with Surgery more than 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Medico-Chirurgicale et Obstetrique Cote d'Opale: lead

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Laura Lecuyer

CONTACT

+33 7 61 83 70 30; llecuyer.clinconsult@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: December 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share