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Study of Walk in Patients With Pelvic Fixation (FBPM)

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ClinicalTrials.gov Identifier: NCT03434184
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Scoliosis

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.


Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Prospective Comparative Study Before and After Spinal Surgery for Scoliosis With Pelvic Fixation in Patients
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434184


Contacts
Contact: Lotfi MILADI, MD +33 (0)1 71 19 62 82 l.miladi@aphp.fr
Contact: Hélène Morel +33 (0)1 71 19 63 46 helene.morel@aphp.fr

Locations
France
Hopital Necker Enfants Malades Recruiting
Paris, France, 75015
Contact: Lotfi MILADI, MD    +33 (0)1 71 19 62 82    l.miladi@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Lotfi MILADI, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03434184     History of Changes
Other Study ID Numbers: NI17021J
2017-A02486-47 ( Other Identifier: ID-RCB )
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Walking analysis
spinal surgery
scoliosis
pelvic fixation

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases