Study of Walk in Patients With Pelvic Fixation
FBPM
Observational Prospective Comparative Study Before and After Spinal Surgery for Scoliosis With Pelvic Fixation in Patients
2 other identifiers
observational
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedStudy Start
First participant enrolled
October 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2023
CompletedSeptember 15, 2025
September 1, 2025
4.4 years
January 24, 2018
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
6 months before and 6 months after spinal surgery
Secondary Outcomes (7)
presence / absence of cardiac impairment
6 months before spinal surgery
presence / absence of respiratory impairment
6 months before spinal surgery
presence / absence of neurological impairment
6 months before spinal surgery
Change in reducibility of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery
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
6 months before and 6 months after spinal surgery
- +2 more secondary outcomes
Eligibility Criteria
Patients under 18 years of age who are walking requiring spinal instrumentation taking the pelvis taken care of in the orthopedic department of NECKER.
You may qualify if:
- Patient under 18 walking or strolling
- Patient with scoliosis requiring long instrumentation taking pelvis with iliosacral screws
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Necker Enfants Malades
Paris, 75015, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lotfi MILADI, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2018
First Posted
February 15, 2018
Study Start
October 12, 2018
Primary Completion
March 16, 2023
Study Completion
March 16, 2023
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share