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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 : February 27, 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 Phase
Scoliosis Procedure: arthrodesis with autologous bone graft Procedure: arthrodesis without bone graft Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft
Actual Study Start Date : December 6, 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: surgery with graft Procedure: arthrodesis with autologous bone graft
arthrodesis with autologous bone graft and using pedicular ilio-sacred EUROS ® screw

Experimental: surgery without graft Procedure: arthrodesis without bone 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
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

Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03331094     History of Changes
Other Study ID Numbers: SCOSANGREFFE
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 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