Quality of LifeKEOPSNCT02886260
Establishing a Descriptive Cohort of Patients Cared for Operation on the Spine
An observational study of Quality of Life and Spinal Injuries, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Spinal Injuries, Spinal Diseases
- How many people
- 193 participants
- Where
- 1 siteFrance
- Study dates
- 21 Aug 2012to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with symptomatic spinal pathology requiring surgical or orthopedic treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Quality of Life, Spinal Injuries, Spinal Diseases
- Medical subject headings
- Spinal Injuries, Spinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured by the Oswestry Disability Index score
Measured: 24 months after surgical intervention
Secondary outcomes (1)
Quality of life measured by the Oswestry Disability Index score
Measured: 6 weeks, 12 weeks, 6 months, 12 months, 36 months, 48 months after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start21 Aug 2012
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886260
- Sponsor's protocol ID
- LOCAL/2011/PK-01
- Acronym
- KEOPS
- Status last verified
- Jun 2026
- First submitted
- 29 Aug 2016
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Descriptive Cohort of Patients Cared for Operation on the Spine
- ClinicalTrials.gov ID
- NCT02886260
- Acronym / sponsor ID
- KEOPS / LOCAL/2011/PK-01
- Conditions
- Quality of Life, Spinal Injuries, Spinal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 21 Aug 2012 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with symptomatic spinal pathology requiring surgical or orthopedic treatment
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life measured by the Oswestry Disability Index score
Time frame: 24 months after surgical intervention
1 secondary outcome
Quality of life measured by the Oswestry Disability Index score
Time frame: 6 weeks, 12 weeks, 6 months, 12 months, 36 months, 48 months after surgical intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Spinal Injuries, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measured by the Oswestry Disability Index score (time frame: 24 months after surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.