Spinal DeformityCOFTASDNCT05108948
Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)
An observational study of Spinal Deformity, run by Elsan at 1 site in France.
Trial summary
The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Deformity
- What is being tested?
- Quality of life questionnaires and Radiography
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 866 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2021to 23 Oct 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient over 18 years-old with spinal deformity operated
Who may be able to join
- Age over 18 years-old
- Diagnosis of Adult Spinal Deformity with any of the deformity characteristics following:
- Scoliosis with a Cobb angle ≥ 20 °
- Vertical sagittal axis (SVA) ≥ 5 cm
- Pelvic tilt ≥25 °,
- Thoracic kyphosis with a Cobb angle ≥ 60 °
Show all 9Show fewer
- Eligible for surgery
- Having given their participation agreement
- Affiliate or beneficiary of a social security scheme
Who cannot join
- Age under 18 years-old
- Patient unlikely to comply with follow-up
- Patient with long-term complete paraplegia
- Patient unable to understand and answer questionnaires in due to language difficulties or cognitive impairment
- Pregnant or breastfeeding woman
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Clinique du dos
Bruges, 33520
Ibrahim Obeid, Dr, ibrahim.obeid@gmail.com
About this study
Official title: Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity : Observational Study (COFTASD)
The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.
- Conditions
- Spinal Deformity
- Being tested
- Quality of life questionnaires, Radiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnairesBehavioural
Oswestry Disability Index Scoliosis Research Society-22R Short Form 36 Health Survey Questionnaire Tobacco, Alcohol, Prescription medication, and other Substance use Core Outcome Measures Index : back and neck
RadiographyProcedure or surgery
Spinal radiography : full, face, profile
| Study group | Role | What they receive |
|---|---|---|
| Spinal deformity operated patients | Not described Receives: Behavioral: Quality of life questionnaires; Procedure: Radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors associated with improved oswestry disability score
The factors associated with an improvement in the ODI score, 1 year after surgery, will be sought among the initial characteristics (before surgery) and within 3 months after surgery. An improvement in ODI score is defined as a decrease in score at 1 year of at least 10 points from baseline.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start23 Oct 2021
- Primary completion23 Oct 2031 (estimated)
- Study completion23 Oct 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- 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
- 866 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108948
- Sponsor's protocol ID
- 2021-A01753-38
- Acronym
- COFTASD
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2021
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity : Observational Study (COFTASD)
- ClinicalTrials.gov ID
- NCT05108948
- Acronym / sponsor ID
- COFTASD / 2021-A01753-38
- Conditions
- Spinal Deformity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 866 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 23 Oct 2021 (actual)
- Primary completion
- 23 Oct 2031 (estimated)
- Study completion
- 23 Oct 2041 (estimated)
- First posted
- 5 Nov 2021 (actual)
- 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.
The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal deformity operated patients | – | Behavioral: Quality of life questionnaires, Procedure: Radiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 18 years-old with spinal deformity operated
Key inclusion criteria (9 listed)
- Age over 18 years-old
- Diagnosis of Adult Spinal Deformity with any of the deformity characteristics following:
- Eligible for surgery
- Having given their participation agreement
- Affiliate or beneficiary of a social security scheme
Key exclusion criteria (6 listed)
- Age under 18 years-old
- Patient unlikely to comply with follow-up
- Patient with long-term complete paraplegia
- Patient unable to understand and answer questionnaires in due to language difficulties or cognitive impairment
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnairesOswestry Disability Index Scoliosis Research Society-22R Short Form 36 Health Survey Questionnaire Tobacco, Alcohol, Prescription medication, and other Substance use Core Outcome Measures Index : back and neck | Behavioural | Spinal deformity operated patients |
| RadiographySpinal radiography : full, face, profile | Procedure or surgery | Spinal deformity operated patients |
Primary outcome
Factors associated with improved oswestry disability score
Time frame: 15 years
The factors associated with an improvement in the ODI score, 1 year after surgery, will be sought among the initial characteristics (before surgery) and within 3 months after surgery. An improvement in ODI score is defined as a decrease in score at 1 year of at least 10 points from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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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.
Marie-Hélène Barba contact
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 Spinal Deformity, run by Elsan 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors associated with improved oswestry disability score (time frame: 15 years). 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 29 Feb 2024.