Study of Walk in Patients With Pelvic Fixation

Scoliosis Clinical Trial

— FBPM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434184
• Other study ID #: NI17021J
• Secondary ID: 2017-A02486-47
• Status: Completed
• Start date: October 12, 2018
• Est. completion date: March 16, 2023

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Locations

Country	Name	City	State
France	Hopital Necker Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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