Establishing a Descriptive Cohort of Patients Cared for O... | NCT02886260

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

NCT02886260

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jun 17, 2026Actual

Enrollment

193Actual

Phase

Not provided

Conditions

Quality of Life
Spinal Injuries
Spinal Diseases

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 21, 2012Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Aug 29, 2016

First Submission Date that Met QC Criteria

Aug 29, 2016

First Posted Date

Sep 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2026

Last Update Posted Date

Jun 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

193Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life measured by the Oswestry Disability Index score		24 months after surgical intervention

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with symptomatic spinal pathology requiring surgical or orthopedic treatment

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU Nimes		Nîmes		30000	France

Condition Browse Module

MeSH Terms

ID	Term
D013124	Spinal Injuries
D013122	Spinal Diseases

Ancestor Terms

ID	Term
D019567	Back Injuries
D014947	Wounds and Injuries
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided