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Biomed Res Int. 2015;2015:173872. doi: 10.1155/2015/173872. Epub 2015 Dec 30.

Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study.

Author information

1
Valladolid University Hospital, Royal Academy of Medicine and Surgery, 47008 Valladolid, Spain.
2
Department of Orthopedic Surgery, Spine Unit, HFR Fribourg-Cantonal Hospital, 1708 Fribourg, Switzerland.
3
Department of Orthopedics, Toulouse Lautrec Clinic, 81030 Albi, France.
4
Department of Neurosurgery, A.R.N.A.S. Civico Di Cristina Benfratelli, 90127 Palermo, Italy.
5
Department of Orthopedic Surgery, University Hospital of Rouen, 76031 Rouen, France.
6
Department of Orthopedic Surgery, Hospital Beaujon, 92110 Clichy, France.
7
Department of Trauma and Orthopedic Surgery, Südostbayern AG Clinic, Traunstein Clinic, 83278 Traunstein, Germany.
8
Department of Spine Surgery, Loretto Hospital, 79100 Freiburg, Germany.
9
LKH-Univ. Klinikum Graz, 8036 Graz, Austria.
10
Department of Neurosurgery, Clinic of Cèdres, 31700 Cornebarrieu, France.
11
Department of Neuroradiology, Regional University Hospital, 14033 Caen, France.
12
Department of Traumatology and Orthopedic Surgery, University Hospital Principe De Asturias, 28805 Madrid, Spain.
13
Department of Radiology, Bois-Cerf Clinic, 1006 Lausanne, Switzerland.
14
Department of Neurosurgery Spine, Private Hospital Sévigné, 35567 Cesson-Sévigné, France.
15
Department of Trauma and Reconstructive Surgery, Philipps University of Marburg, University Hospital of Giessen and Marburg, 35043 Marburg, Germany.

Abstract

This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4 ± 6.3°; p < 0.001), remained at 12 months (-4.4 ± 6.0°, p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

PMID:
26844224
PMCID:
PMC4710926
DOI:
10.1155/2015/173872
[Indexed for MEDLINE]
Free PMC Article

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