Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

NCT ID: NCT03331094

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-06

Study Completion Date

2023-12-30

Brief Summary

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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

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Conditions

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Scoliosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Surgery with graft

Intervention Type PROCEDURE

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.

surgery without graft

Intervention Type PROCEDURE

arthrodesis without bone graft using pedicular ilio-sacred EUROS ® screw

Interventions

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Surgery with graft

arthrodesis with autologous bone graft and using pedicular ilio-sacred EUROS ® screw

Intervention Type PROCEDURE

surgery without graft

arthrodesis without bone graft using pedicular ilio-sacred EUROS ® screw

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* minor patient
* surgery not including the pelvis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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WOLFF Stephane, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

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Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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WOLFF Stephane, MD

Role: CONTACT

01 44 12 33 33

RIOUALLON Guillaume, MD

Role: CONTACT

01 44 12 33 33

Facility Contacts

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Helene BEAUSSIER, PharmD, PhD

Role: primary

Other Identifiers

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SCOSANGREFF

Identifier Type: -

Identifier Source: org_study_id

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