Clinical trial NCT03434184: Study of Walk in Patients With Pelvic Fixation
Official title: Observational Prospective Comparative Study Before and After Spinal Surgery for Scoliosis With Pelvic Fixation in Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Keywords: Walking analysis
spinal surgery
scoliosis
pelvic fixation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 6
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the score of CPCHILD (section 2) questionnaire from 6 months before spinal surgery at 6 month after spinal surgery
timeFrame: 6 months before and 6 months after spinal surgery
measure: Change in Clinical Gait Analysis from 6 months before spinal surgery at 6 month after spinal surgery
timeFrame: 6 months before and 6 months after spinal surgery
measure: Change in 6-minute walking test from 6 months before spinal surgery at 6 month after spinal surgery
timeFrame: 6 months before and 6 months after spinal surgery
Secondary outcomes:
measure: presence / absence of cardiac impairment
timeFrame: 6 months before spinal surgery
measure: presence / absence of respiratory impairment
timeFrame: 6 months before spinal surgery
measure: presence / absence of neurological impairment
timeFrame: 6 months before spinal surgery
measure: Change in reducibility of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery
timeFrame: 6 months before and 6 months after spinal surgery
measure: Change in "holding of the head " of scoliosis : from 6 months before spinal surgery at 6 month after spinal surgery
timeFrame: 6 months before and 6 months after spinal surgery
measure: Change in curvature of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery
timeFrame: 6 months before and 6 months after spinal surgery
measure: Change in imbalance of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery
timeFrame: 6 months before and 6 months after spinal surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Lotfi MILADI, MD
role: PRINCIPAL_INVESTIGATOR
References: