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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03331094
Other study ID # SCOSANGREFF
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 6, 2016
Est. completion date December 30, 2023

Study information

Verified date March 2023
Source Groupe Hospitalier Paris Saint Joseph
Contact WOLFF Stephane, MD
Phone 01 44 12 33 33
Email swolff@hpsj.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date December 30, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age >18 - under guardianship - vertebral deformation >20° - accept to participate Exclusion Criteria: - minor patient - surgery not including the pelvis

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgery with graft
arthrodesis with autologous bone graft and using pedicular ilio-sacred EUROS ® screw
surgery without graft
arthrodesis without bone graft using pedicular ilio-sacred EUROS ® screw

Locations

Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of Cobb angle Cobb angle represent the degree of curvature of the scoliosis change from baseline Cobb angle at 6 months
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