title: Safety and clinical performance of kyphoplasty and SpineJack(®) procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.
abstract: Clinical performance and safety of two percutaneous vertebral cement augmentation (VA) procedures (SpineJack® and Kyphx Xpander® balloon) were compared in patients with osteoporotic compression fractures. Both techniques were safe, efficient, and led to a rapid and marked improvement in clinical signs; nevertheless, SpineJack showed better restoration of vertebral heights and angles, maintained over time.
  
  
  
  In patients with osteoporotic vertebral compression fractures (VCFs), both SpineJack® (SJ) and balloon kyphoplasty (BKP) led to a rapid and marked improvement in clinical signs. This pilot, monocentric, investigator-initiated, prospective study aimed to compare two percutaneous vertebral augmentation procedures in the painful osteoporotic VCF treatment.
  
  
  
  Thirty patients were randomized to receive SJ (n = 15) or BKP (n = 15). Analgesic consumption, back pain intensity (visual analog scale (VAS)), and Oswestry Disability Index (ODI) scores were recorded preoperatively, at 5 days and 1, 3, 6, and 12 months post-surgery. Quality of life (EQ-VAS score) was evaluated at 1, 3, 6, and 12 months. Spine X-rays were taken 48 h prior to procedure and 5 days and 6 and 12 months after.
  
  
  
  SpineJack® led to a significantly shorter intervention period (23 vs 32 min; p < 0.001), a strong, rapid, and long-lasting decline in pain (94 vs 82 % at 12 months) and in functional disability (94 vs 90 % at 12 months), a greater and sustainable mean correction of anterior (12 ± 13 vs 0 ± 7 % for BKP, p = 0.003) and central height (12 ± 10 vs 2 ± 6 % for BKP, p = 0.001) at 12 months, and a larger restoration of the vertebral body angle still evident 12 months after implantation (-4.4° ± 5.8° vs 0.2° ± 3.0° for BKP; p = 0.012).
  
  
  
  This pilot study showed that both techniques were safe and efficient for the osteoporotic VCF treatment. Radiological results indicate that the SpineJack® procedure has a higher potential for vertebral body height restoration and maintenance over time.
authors: Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008, Valladolid, Spain. noriega1970@icloud.com.
authors: D C
authors: DC
authors: Noriega
authors: Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008, Valladolid, Spain.
authors: R H
authors: RH
authors: Ramajo
authors: Servicio de Radiología, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008, Valladolid, Spain.
authors: I S
authors: IS
authors: Lite
authors: Servicio de Radiología, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008, Valladolid, Spain.
authors: B
authors: B
authors: Toribio
authors: Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008, Valladolid, Spain.
authors: R
authors: R
authors: Corredera
authors: Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008, Valladolid, Spain.
authors: F
authors: F
authors: Ardura
authors: Center for Orthopaedics and Trauma Surgery, University Hospital Giessen and Marburg GmbH, Marburg, Baldingerstraße, 35043, Marburg, Germany.
authors: A
authors: A
authors: Krüger
mesh_terms: D000368:Aged; D001843:Bone Cements; D005260:Female; D050815:Fractures, Compression / Q000601:surgery*; D006801:Humans; D058498:Kyphoplasty; D008297:Male; D008875:Middle Aged; D058866:Osteoporotic Fractures / Q000601:surgery*; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D016103:Spinal Fractures / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D001843:Bone Cements
keywords: Back pain; Balloon kyphoplasty; Osteoporosis; SpineJack; Vertebral augmentation; Vertebral compression fracture