Study of Walk in Patients With Pelvic Fixation
- Conditions
- Scoliosis
- Registration Number
- NCT03434184
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- Patient under 18 walking or strolling
- Patient with scoliosis requiring long instrumentation taking pelvis with iliosacral screws
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the score of CPCHILD (section 2) questionnaire from 6 months before spinal surgery at 6 month after spinal surgery 6 months before and 6 months after spinal surgery to assess the quality criteria of walk
Change in Clinical Gait Analysis from 6 months before spinal surgery at 6 month after spinal surgery 6 months before and 6 months after spinal surgery to assess the quantitative criteria of walk
Change in 6-minute walking test from 6 months before spinal surgery at 6 month after spinal surgery 6 months before and 6 months after spinal surgery to assess the quantitative criteria of walk
- Secondary Outcome Measures
Name Time Method 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 to evaluate the good or bad prognosis for walking
presence / absence of cardiac impairment 6 months before spinal surgery cardiac evaluation to evaluate assess if cardiac impairment before spinal surgery is a the good or bad prognosis for walking
presence / absence of neurological impairment 6 months before spinal surgery neurological evaluation to assess if neurology impairment before spinal surgery is a good or bad prognosis for walking
Change in imbalance of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery 6 months before and 6 months after spinal surgery to evaluate the good or bad prognosis for walking
presence / absence of respiratory impairment 6 months before spinal surgery pulmonary evaluation to assess if respiratory impairment before spinal surgery is a good or bad prognosis for walking
Change in curvature of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery 6 months before and 6 months after spinal surgery to evaluate the good or bad prognosis for walking
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 to evaluate the good or bad prognosis for walking
Trial Locations
- Locations (1)
Hopital Necker Enfants Malades
🇫🇷Paris, France