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

NCT02886260 | Unknown

• 1 other identifier: LOCAL/2011/PK-01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to:

1. 1.describe the monitoring of patients treated for spinal disorders.
2. 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. 3.obtain a cohort of patients in the comprehensive range of spinal pathologies.
4. 4.standardize data collection in this cohort with similar national projects.

Conditions

Quality of Life; Spinal Injuries; Spinal Diseases

Outcome Measures

Primary Outcomes (1)

• Quality of life measured by the Oswestry Disability Index score

  24 months after surgical intervention

Secondary Outcomes (1)

• 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

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 with symptomatic spinal pathology requiring surgical or orthopedic treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30000, France

RECRUITING

MeSH Terms

Conditions

Spinal Injuries; Spinal Diseases

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

CHU Nimes

CONTACT

Study Design

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

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: August 28, 2012
• Primary Completion: June 26, 2017
• Study Completion: October 1, 2022
• Last Updated: August 5, 2021

Record last verified: 2021-08

Locations

FR (1)