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Study of Walk in Patients With Pelvic Fixation

Observational Prospective Comparative Study Before and After Spinal Surgery for Scoliosis With Pelvic Fixation in Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03434184
Acronym
FBPM
Enrollment
6
Registered
2018-02-15
Start date
2018-10-12
Completion date
2023-03-16
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

Walking analysis, spinal surgery, scoliosis, pelvic fixation

Brief 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.

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.

Interventions

None listed

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* Patient under 18 walking or strolling * Patient with scoliosis requiring long instrumentation taking pelvis with iliosacral screws

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in the score of CPCHILD (section 2) questionnaire from 6 months before spinal surgery at 6 month after spinal surgery6 months before and 6 months after spinal surgeryto assess the quality criteria of walk
Change in Clinical Gait Analysis from 6 months before spinal surgery at 6 month after spinal surgery6 months before and 6 months after spinal surgeryto assess the quantitative criteria of walk
Change in 6-minute walking test from 6 months before spinal surgery at 6 month after spinal surgery6 months before and 6 months after spinal surgeryto assess the quantitative criteria of walk

Secondary

MeasureTime frameDescription
Change in reducibility of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery6 months before and 6 months after spinal surgeryto evaluate the good or bad prognosis for walking
Change in holding of the head of scoliosis : from 6 months before spinal surgery at 6 month after spinal surgery6 months before and 6 months after spinal surgeryto evaluate the good or bad prognosis for walking
presence / absence of cardiac impairment6 months before spinal surgerycardiac evaluation to evaluate assess if cardiac impairment before spinal surgery is a the good or bad prognosis for walking
Change in imbalance of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery6 months before and 6 months after spinal surgeryto evaluate the good or bad prognosis for walking
Change in curvature of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery6 months before and 6 months after spinal surgeryto evaluate the good or bad prognosis for walking
presence / absence of respiratory impairment6 months before spinal surgerypulmonary evaluation to assess if respiratory impairment before spinal surgery is a good or bad prognosis for walking
presence / absence of neurological impairment6 months before spinal surgeryneurological evaluation to assess if neurology impairment before spinal surgery is a good or bad prognosis for walking

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026