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Trials / Completed

CompletedNCT03434184

Study of Walk in Patients With Pelvic Fixation

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

Status
Completed
Phase
Study type
Observational
Enrollment
6 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2018-10-12
Primary completion
2023-03-16
Completion
2023-03-16
First posted
2018-02-15
Last updated
2025-09-15

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03434184. Inclusion in this directory is not an endorsement.

Study of Walk in Patients With Pelvic Fixation (NCT03434184) · Clinical Trials Directory