ScoliosisFBPMNCT03434184
Study of Walk in Patients With Pelvic Fixation
An observational study of Scoliosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine the effect of double end spinal instrumentation from the upper thoracic to the pelvis with sacro-iliac fixation on the gait of ambulating patients with pelvic obliquity 6 month after surgery. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Scoliosis
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2018to 16 Mar 2023
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients under 18 years of age who are walking requiring spinal instrumentation taking the pelvis taken care of in the orthopedic department of NECKER.
Who may be able to join
- Patient under 18 walking or strolling
- Patient with scoliosis requiring long instrumentation taking pelvis with iliosacral screws
Who cannot join
- Patient presenting a predictable pejorative evolution of the walk due to the pathology of the patient within 2 years
- Patient or parent who has notified their refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Prospective Comparative Study Before and After Spinal Surgery for Scoliosis With Pelvic Fixation in Patients
The purpose of this study is to determine the effect of double end spinal instrumentation from the upper thoracic to the pelvis with sacro-iliac fixation on the gait of ambulating patients with pelvic obliquity 6 month after surgery.
Read the detailed description
The pelvic fixations were used since many years for these patients. However there are no prospective study investigating the gait evolution before and after a surgical treatment by long spinal instrumentation with pelvic fixation.
Investigators are planning to analyze the gait, before and 6 months after surgery. Investigators will use 2 qualitative criterions with a gait analysis and a walking test, and 1 quantitative criterion with a questionnaire assessing the patient's functional change. Investigators will use as surgical treatment a long double end spinal fixation without fusion, investigators use an ilio sacral screw as pelvic anchor on each side.
Evaluation of changes in gait after pelvic fixation of a long spinal instrumentation will make it possible to extend or, on the contrary, restrict the indications for pelvic fixation surgery in walking patients, who are candidates for pelvic fixation.
- Conditions
- Scoliosis
- Keywords
- Walking analysis, spinal surgery, scoliosis, pelvic fixation
- Medical subject headings
- Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the score of CPCHILD (section 2) questionnaire from 6 months before spinal surgery at 6 month after spinal surgery
to assess the quality criteria of walk
Measured: 6 months before and 6 months after spinal surgery
Change in Clinical Gait Analysis from 6 months before spinal surgery at 6 month after spinal surgery
to assess the quantitative criteria of walk
Measured: 6 months before and 6 months after spinal surgery
Change in 6-minute walking test from 6 months before spinal surgery at 6 month after spinal surgery
to assess the quantitative criteria of walk
Measured: 6 months before and 6 months after spinal surgery
Secondary outcomes (7)
presence / absence of cardiac impairment
cardiac evaluation to evaluate assess if cardiac impairment before spinal surgery is a the good or bad prognosis for walking
Measured: 6 months before spinal surgery
presence / absence of respiratory impairment
pulmonary evaluation to assess if respiratory impairment before spinal surgery is a good or bad prognosis for walking
Measured: 6 months before spinal surgery
presence / absence of neurological impairment
neurological evaluation to assess if neurology impairment before spinal surgery is a good or bad prognosis for walking
Measured: 6 months before spinal surgery
Change in reducibility of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery
to evaluate the good or bad prognosis for walking
Measured: 6 months before and 6 months after spinal surgery
Change in "holding of the head " of scoliosis : from 6 months before spinal surgery at 6 month after spinal surgery
to evaluate the good or bad prognosis for walking
Measured: 6 months before and 6 months after spinal surgery
Change in curvature of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery
to evaluate the good or bad prognosis for walking
Measured: 6 months before and 6 months after spinal surgery
Change in imbalance of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery
to evaluate the good or bad prognosis for walking
Measured: 6 months before and 6 months after spinal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start12 Oct 2018
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Lotfi MILADI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434184
- Sponsor's protocol ID
- NI17021J
- Other IDs
- 2017-A02486-47
- Acronym
- FBPM
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2018
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Comparative Study Before and After Spinal Surgery for Scoliosis With Pelvic Fixation in Patients
- ClinicalTrials.gov ID
- NCT03434184
- Acronym / sponsor ID
- FBPM / NI17021J
- Conditions
- Scoliosis
- Keywords
- Walking analysis, spinal surgery, scoliosis, pelvic fixation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 15 Feb 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 purpose of this study is to determine the effect of double end spinal instrumentation from the upper thoracic to the pelvis with sacro-iliac fixation on the gait of ambulating patients with pelvic obliquity 6 month after surgery.
Detailed description
The pelvic fixations were used since many years for these patients. However there are no prospective study investigating the gait evolution before and after a surgical treatment by long spinal instrumentation with pelvic fixation.
Investigators are planning to analyze the gait, before and 6 months after surgery. Investigators will use 2 qualitative criterions with a gait analysis and a walking test, and 1 quantitative criterion with a questionnaire assessing the patient's functional change. Investigators will use as surgical treatment a long double end spinal fixation without fusion, investigators use an ilio sacral screw as pelvic anchor on each side.
Evaluation of changes in gait after pelvic fixation of a long spinal instrumentation will make it possible to extend or, on the contrary, restrict the indications for pelvic fixation surgery in walking patients, who are candidates for pelvic fixation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients under 18 years of age who are walking requiring spinal instrumentation taking the pelvis taken care of in the orthopedic department of NECKER.
Key inclusion criteria (2 listed)
- Patient under 18 walking or strolling
- Patient with scoliosis requiring long instrumentation taking pelvis with iliosacral screws
Key exclusion criteria (2 listed)
- Patient presenting a predictable pejorative evolution of the walk due to the pathology of the patient within 2 years
- Patient or parent who has notified their refusal to participate
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
Change in the score of CPCHILD (section 2) questionnaire from 6 months before spinal surgery at 6 month after spinal surgery
Time frame: 6 months before and 6 months after spinal surgery
to assess the quality criteria of walk
Change in Clinical Gait Analysis from 6 months before spinal surgery at 6 month after spinal surgery
Time frame: 6 months before and 6 months after spinal surgery
to assess the quantitative criteria of walk
Change in 6-minute walking test from 6 months before spinal surgery at 6 month after spinal surgery
Time frame: 6 months before and 6 months after spinal surgery
to assess the quantitative criteria of walk
7 secondary outcomes
presence / absence of cardiac impairment
Time frame: 6 months before spinal surgery
presence / absence of respiratory impairment
Time frame: 6 months before spinal surgery
presence / absence of neurological impairment
Time frame: 6 months before spinal surgery
Change in reducibility of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery
Time frame: 6 months before and 6 months after spinal surgery
Change in "holding of the head " of scoliosis : from 6 months before spinal surgery at 6 month after spinal surgery
Time frame: 6 months before and 6 months after spinal surgery
Change in curvature of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery
Time frame: 6 months before and 6 months after spinal surgery
Change in imbalance of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery
Time frame: 6 months before and 6 months after spinal surgery
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 15 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Lotfi MILADI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Scoliosis, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 2 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 15 Sep 2025. 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?
Change in the score of CPCHILD (section 2) questionnaire from 6 months before spinal surgery at 6 month after spinal surgery (time frame: 6 months before and 6 months after spinal surgery). The study lists 3 primary outcomes in all. 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 15 Sep 2025.