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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Spine fracture management for traumatic vertebral compression fracture
Surgical corset according to measurement's impression, rigid corset with sternal support
Hopital Jean Minjoz Besancon
Besançon, France
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, France
CHU Brest
Brest, France
Centre Hospitalier De Chambéry
Chambéry, France
VAS
Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up
Time frame: 1 and 12 months follow-up
Oswestry Disability Index
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
EQ-5D
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Kyphotic angle
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Regional Kyphotic Angle
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Evaluation of safety through evaluation of adverse events
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Costs comparison of overall treatments
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
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CHU de Dijon
Dijon, France
APHM, Hopital Nord Marseille
Marseille, France
CHU de Rennes
Rennes, France
CHU de Rouen-Hopital Charles Nicolle
Rouen, France
Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire, France