Study of Walk in Patients With Pelvic Fixation

Assistance Publique - Hôpitaux de Paris6 enrolled

Overview

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.

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

Conditions

Scoliosis

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Necker Enfants Malades

Paris, France

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 6 months before and 6 months after spinal surgery

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 6 months before spinal surgery

Change in reducibility of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery

Data from ClinicalTrials.gov

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