SpineJack® Versus Conservative Treatment Study (SPICO Study)

Status Completed

Clinical Trial Summary

This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows: 1. SpineJack® system 2. Conservative Orthopedic Management consisting of brace and pain medication.

Clinical Trial Description

100 subjects (18 to 60 years old) will be enrolled (1:1) with one to two painful traumatic fractures, non-pathological (types A1 and A3.1 by Magerl Classification). Subjects will be followed at admission, procedure, discharge, 1 month, 3 months, 12 months and 24 months post Vertebral Compression Fracture (VCF) reduction procedure or the set-up of the brace. The estimated enrollment period is 12 months and each patient should perform a 24 months follow-up period. Therefore, the total study duration is estimated to be 36 months for the complete study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02657265
Study type	Interventional
Source	Vexim SA
Contact
Status	Completed
Phase	N/A
Start date	January 13, 2016
Completion date	May 25, 2020

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