Establishing a Descriptive Cohort of Patients Cared for Operation on the Spine

• Conditions: Spinal Injuries; Quality of Life; Spinal Diseases

• Registration Number: NCT02886260
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

This study aims to:

1. describe the monitoring of patients treated for spinal disorders.

2. create a comprehensive database of reliable and readily exploitable quickly to produce a library of cross publications between orthopedic surgery and neurosurgical services. This database will include clinical, functional , radiographic , educational, social and professional data.

3. obtain a cohort of patients in the comprehensive range of spinal pathologies.

4. standardize data collection in this cohort with similar national projects.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-28
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-01
• Primary Completion: 2017-06-26
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• The patient must be given free and informed consent and signed the consent
• The patient must be affiliated or beneficiary of a health insurance plan
• The patient is available for a 24-month follow-up
• The patient is at least 18 years old
• The patient has a symptomatic spinal pathology requiring surgical or orthopedic treatment

Exclusion Criteria

• The patient is under judicial protection, guardianship or curatorship
• The patient refuses to sign the consent
• It is not possible to give informed information to the patient
• The patient does not fluently read French.
• the patient is not available for a 24-month follow-ip

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life measured by the Oswestry Disability Index score	24 months after surgical intervention

Secondary Outcome Measures

Name	Time	Method
Quality of life measured by the Oswestry Disability Index score	6 weeks, 12 weeks, 6 months, 12 months, 36 months, 48 months after surgical intervention

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nimes, France