Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

March 6, 2023 updated by: Groupe Hospitalier Paris Saint Joseph
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: WOLFF Stephane, MD
  • Phone Number: 01 44 12 33 33
  • Email: swolff@hpsj.fr

Study Contact Backup

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Recruiting
        • Groupe hospitalier Paris saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

every patient with a scoliosis responding to the criteria above recovering for surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • minor patient
  • surgery not including the pelvis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of Cobb angle
Time Frame: change from baseline Cobb angle at 6 months
Cobb angle represent the degree of curvature of the scoliosis
change from baseline Cobb angle at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: WOLFF Stephane, MD, Groupe hospitalier Paris saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2016

Primary Completion (Anticipated)

November 15, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCOSANGREFF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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