title: Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study.
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.
authors: Valladolid University Hospital, Royal Academy of Medicine and Surgery, 47008 Valladolid, Spain.
authors: David
authors: D
authors: Noriega
authors: Department of Orthopedic Surgery, Spine Unit, HFR Fribourg-Cantonal Hospital, 1708 Fribourg, Switzerland.
authors: Gianluca
authors: G
authors: Maestretti
authors: Department of Orthopedics, Toulouse Lautrec Clinic, 81030 Albi, France.
authors: Christian
authors: C
authors: Renaud
authors: Department of Neurosurgery, A.R.N.A.S. Civico Di Cristina Benfratelli, 90127 Palermo, Italy.
authors: Natale
authors: N
authors: Francaviglia
authors: Department of Orthopedic Surgery, University Hospital of Rouen, 76031 Rouen, France.
authors: Mourad
authors: M
authors: Ould-Slimane
authors: Department of Orthopedic Surgery, Hospital Beaujon, 92110 Clichy, France.
authors: Steffen
authors: S
authors: Queinnec
authors: Department of Trauma and Orthopedic Surgery, Südostbayern AG Clinic, Traunstein Clinic, 83278 Traunstein, Germany.
authors: Helmut
authors: H
authors: Ekkerlein
authors: Department of Spine Surgery, Loretto Hospital, 79100 Freiburg, Germany.
authors: Frank
authors: F
authors: Hassel
authors: LKH-Univ. Klinikum Graz, 8036 Graz, Austria.
authors: Rainer
authors: R
authors: Gumpert
authors: Department of Neurosurgery, Clinic of Cèdres, 31700 Cornebarrieu, France.
authors: Pascal
authors: P
authors: Sabatier
authors: Department of Neuroradiology, Regional University Hospital, 14033 Caen, France.
authors: Hervé
authors: H
authors: Huet
authors: Department of Traumatology and Orthopedic Surgery, University Hospital Principe De Asturias, 28805 Madrid, Spain.
authors: Miguel
authors: M
authors: Plasencia
authors: Department of Radiology, Bois-Cerf Clinic, 1006 Lausanne, Switzerland.
authors: Nicolas
authors: N
authors: Theumann
authors: Department of Neurosurgery Spine, Private Hospital Sévigné, 35567 Cesson-Sévigné, France.
authors: Alexander
authors: A
authors: Kunsky
authors: Department of Trauma and Reconstructive Surgery, Philipps University of Marburg, University Hospital of Giessen and Marburg, 35043 Marburg, Germany.
authors: Antonio
authors: A
authors: Krüger
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001416:Back Pain / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life; D016103:Spinal Fractures / Q000601:surgery*