Idiopathic ScoliosisRACHIDOLNCT03686371
Evaluation of Pain Following Scoliosis Surgery.
An observational study of Idiopathic Scoliosis, run by Rennes University Hospital at 1 site in France.
Trial summary
The main objective of this study was to evaluate acute pain following scoliosis surgery in adolescent. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- posterior surgery for spinal arthrodesis
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2018to 30 Jun 2019
- 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 10 to 18 years
- All sexes
- Child, Adult
Study population: adolescent with scoliosis surgery for idiopathic scoliosis
Who may be able to join
- adolescent from 10 to 18 years of age
- idiopathic scoliosis
- posterior surgery for spinal arthrodesis
- non opposition children and parents
Who cannot join
- complication following surgery needing reoperation
- secondary intervention
- anterior surgery
- non idiopathic scoliosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pain Following Scoliosis Surgery.- RACHIDOL
The main objective of this study was to evaluate acute pain following scoliosis surgery in adolescent.
- Conditions
- Idiopathic Scoliosis
- Being tested
- posterior surgery for spinal arthrodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior surgery for spinal arthrodesisProcedure or surgery
posterior surgery for spinal arthrodesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score for pain (EVA)
The assessment criteria used is the numerical pain scale from 0 to 10(0 = no pain, 10 = extremely painful
Measured: 3 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start2 Jan 2018
- Primary completion23 Oct 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne DEFONTAINE, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686371
- Sponsor's protocol ID
- 35RC17_3088_RACHIDOL
- Acronym
- RACHIDOL
- Status last verified
- Apr 2023
- First submitted
- 10 Sep 2018
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Following Scoliosis Surgery.- RACHIDOL
- ClinicalTrials.gov ID
- NCT03686371
- Acronym / sponsor ID
- RACHIDOL / 35RC17_3088_RACHIDOL
- Conditions
- Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 26 Sep 2018 (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 main objective of this study was to evaluate acute pain following scoliosis surgery in adolescent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- adolescent with scoliosis surgery for idiopathic scoliosis
Key inclusion criteria (4 listed)
- adolescent from 10 to 18 years of age
- idiopathic scoliosis
- posterior surgery for spinal arthrodesis
- non opposition children and parents
Key exclusion criteria (4 listed)
- complication following surgery needing reoperation
- secondary intervention
- anterior surgery
- non idiopathic scoliosis
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 |
|---|---|---|
| posterior surgery for spinal arthrodesisposterior surgery for spinal arthrodesis | Procedure or surgery | – |
Primary outcome
Visual Analog Score for pain (EVA)
Time frame: 3 days after inclusion
The assessment criteria used is the numerical pain scale from 0 to 10(0 = no pain, 10 = extremely painful
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 13 Apr 2023.
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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.
Anne DEFONTAINE, MD principal investigator
Rennes University Hospital
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 Idiopathic Scoliosis, run by Rennes University Hospital 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 4 inclusion and 4 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 13 Apr 2023. 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?
Visual Analog Score for pain (EVA) (time frame: 3 days after inclusion). 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 13 Apr 2023.