The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
Vertebral augmentation for one osteoporotic vertebral compression fracture
Hôpital Jean Minjoz Service Neurochirurgie
Besançon, France
Centre Hospitalier La Cavale Blanche
Brest, France
CHU La Timone
Marseille, France
Proportion of Participants With Study Success
The primary composite endpoint defines a successful subject if the following components are satisfied (safety and effectiveness): 1. Reduction in VCF fracture-related pain at 12 months from baseline as measured by a 100 mm VAS scale (reduction of pain at 12 months by \> 20 mm) AND, 2. Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI) AND, 3. Absence of device-related serious adverse events, defined as device-related adverse events (device migration, recollapse, protrusion) or symptomatic cement extravasation requiring surgical re-intervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation.
Time frame: 12 month post-op
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Hôpital Nord
Marseille, France
CHU Hôtel Dieu Service Neuro traumatologie
Nantes, France
Klinik und Poliklinik fur Orthopädie Universitatsklinikum
Bonn, Germany
Loretto-Krankenhaus Freiburg
Freiburg im Breisgau, Germany
Krankenhaus NEUWERK Sankt Augustinus kliniken
Mönchengladbach, Germany
Ospedale SS Trinita ASL8
Cagliari, Italy
Hospital Universitario Marques de Valdecilla
Santander, Spain
...and 3 more locations