Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

Sponsor

Groupe Hospitalier Paris Saint Joseph (Other)

Overall Status

Recruiting

CT.gov ID

NCT03331094

Collaborator

(none)

Enrollment

Location

72.8

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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: Surgery with graft Procedure: surgery without graft

Study Design

Study Type:

Observational

Anticipated 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 :

Dec 6, 2016

Anticipated Primary Completion Date :

Sep 15, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

change of Cobb angle [change from baseline Cobb angle at 6 months]
Cobb angle represent the degree of curvature of the scoliosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

minor patient
surgery not including the pelvis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France	France	75014

Sponsors and Collaborators

Groupe Hospitalier Paris Saint Joseph

Investigators

Principal Investigator: WOLFF Stephane, MD, Groupe Hospitalier Paris Saint Joseph

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Groupe Hospitalier Paris Saint Joseph

ClinicalTrials.gov Identifier:

NCT03331094

Other Study ID Numbers:

SCOSANGREFF

First Posted:

Nov 6, 2017

Last Update Posted:

Aug 18, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scoliosis

Study Results

No Results Posted as of Aug 18, 2022