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Trial record 2 of 141 for:    ADULT SCOLIOSIS

Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

This study is currently recruiting participants.
Verified October 2017 by Groupe Hospitalier Paris Saint Joseph
Sponsor:
ClinicalTrials.gov Identifier:
NCT03331094
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph
  Purpose
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 Intervention
Scoliosis Procedure: arthrodesis with autologous bone graft Procedure: arthrodesis without bone graft

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Paris Saint Joseph:

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


Estimated Enrollment: 60
Actual Study Start Date: December 6, 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03331094     History of Changes
Other Study ID Numbers: SCOSANGREFFE
First Submitted: October 24, 2017
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017

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