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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis

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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	6 months before and 6 months after spinal surgery

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Lotfi MILADI, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2018
• Primary Completion (Actual): March 16, 2023
• Study Completion (Actual): March 16, 2023

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: spinal surgery; scoliosis; Walking analysis; pelvic fixation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: NI17021J; 2017-A02486-47 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No