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Completed

NCT Number: NCT03434184

Study of Walk in Patients With Pelvic Fixation

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Necker Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in the score of CPCHILD (section 2) questionnaire from 6 months before spinal surgery at 6 month after spinal surgery

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

    to assess the quality criteria of walk

  2. Change in Clinical Gait Analysis from 6 months before spinal surgery at 6 month after spinal surgery

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

    to assess the quantitative criteria of walk

  3. Change in 6-minute walking test from 6 months before spinal surgery at 6 month after spinal surgery

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

    to assess the quantitative criteria of walk

Secondary outcomes

  1. presence / absence of cardiac impairment

    Time frame: 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

  2. presence / absence of respiratory impairment

    Time frame: 6 months before spinal surgery

    pulmonary evaluation to assess if respiratory impairment before spinal surgery is a good or bad prognosis for walking

  3. presence / absence of neurological impairment

    Time frame: 6 months before spinal surgery

    neurological evaluation to assess if neurology impairment before spinal surgery is a good or bad prognosis for walking

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

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

    to evaluate the good or bad prognosis for walking

  5. Change in "holding of the head " of scoliosis : from 6 months before spinal surgery at 6 month after spinal surgery

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

    to evaluate the good or bad prognosis for walking

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

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

    to evaluate the good or bad prognosis for walking

  7. Change in imbalance of scoliosis from 6 months before spinal surgery at 6 month after spinal surgery

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

    to evaluate the good or bad prognosis for walking

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: FBPM

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2018
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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