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Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

Recruiting
Conditions
Scoliosis
Interventions
Procedure: Surgery with graft
Procedure: surgery without graft
Registration Number
NCT03331094
Lead Sponsor
Fondation Hôpital 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
96
Inclusion Criteria
  • age >18
  • under guardianship
  • vertebral deformation >20°
  • accept to participate
Exclusion Criteria
  • minor patient
  • surgery not including the pelvis

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
surgery with graftSurgery with graftThe 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.
surgery without graftsurgery without graftAdult scoliosis surgery is performed with instrumentation without grafting: the teams use variable stiffness rods made of metal or PEEK.
Primary Outcome Measures
NameTimeMethod
change of Cobb anglechange from baseline Cobb angle at 6 months

Cobb angle represent the degree of curvature of the scoliosis

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint Joseph

🇫🇷

Paris, Ile-de-France, France

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