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Trial record 3 of 148 for:    ADULT SCOLIOSIS

Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

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ClinicalTrials.gov Identifier: NCT03331094
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:
The objective of the study will be to estimate the correction obtained with a metallic instrumentation, by mini-invasive technique with bipolar assembly and ilio-sacred EUROS ®) screw , without transplant at the adult as compared to that obtained with the surgery with complete exhibition of the rachis and bone graft.

Condition or disease Intervention/treatment
Scoliosis Procedure: Surgery with graft Procedure: surgery without graft

Study Type : Observational
Estimated Enrollment : 96 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft
Actual Study Start Date : December 6, 2016
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort Intervention/treatment
surgery with graft
The procedure is to place a metal instrumentation (rods and screws) in contact with the spine to correct the deformity. Added to this is a graft between the vertebrae that will allow a bone bridge of ankylosis making the spine completely rigid.
Procedure: Surgery with graft
arthrodesis with autologous bone graft and using pedicular ilio-sacred EUROS ® screw

surgery without graft
Adult scoliosis surgery is performed with instrumentation without grafting: the teams use variable stiffness rods made of metal or PEEK.
Procedure: surgery without graft
arthrodesis without bone graft using pedicular ilio-sacred EUROS ® screw




Primary Outcome Measures :
  1. change of Cobb angle [ Time Frame: change from baseline Cobb angle at 6 months ]
    Cobb angle represent the degree of curvature of the scoliosis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
every patient with a scoliosis responding to the criteria above recovering for surgery
Criteria

Inclusion Criteria:

  • age >18
  • under guardianship
  • vertebral deformation >20°
  • accept to participate

Exclusion Criteria:

  • minor patient
  • surgery not including the pelvis

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): NCT03331094


Contacts
Contact: WOLFF Stephane, MD 01 44 12 33 33 swolff@hpsj.fr
Contact: RIOUALLON Guillaume, MD 01 44 12 33 33 griouallon@hpsj.fr

Locations
France
Groupe Hospitalier Paris Saint Joseph Recruiting
Paris, Ile-de-France, France, 75014
Contact: Helene BEAUSSIER, PharmD, PhD         
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Principal Investigator: WOLFF Stephane, MD Groupe Hospitalier Paris Saint Joseph

Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03331094     History of Changes
Other Study ID Numbers: SCOSANGREFF
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

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

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