Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2016
Safety and clinical performance of kyphoplasty and SpineJack(®) procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.
Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 84 citations in OpenAlex.
- Therapeutic Efficacy of Third-Generation Percutaneous Vertebral Augmentation System (PVAS) in Osteoporotic Vertebral Compression Fractures (OVCFs): A Systematic Review and Meta-analysis.BioMed research international · 2022Pooled it
- Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019Trial
- Procedural Complications and Implant Cutout of the SpineJack®-System in Thoracolumbar Vertebral Fractures: A Retrospective Analysis of 204 Implants from a Level-1 Trauma Center.Global spine journal · 2026Article
- Mechanical augmentation for vertebral compression fractures: A scoping review.Interventional pain medicine · 2026Review
- Finite element modeling and experimental validation of wedge fractures in the thoracic spine.Spine deformity · 2026Article
- L1 vertebral body replacement using 3D-printed polylactic acid bioimplants:Journal of spine surgery (Hong Kong) · 2025Article
- Efficacy and safety of vertebral augmentation techniques in patients with osteoporotic vertebral compression fractures: A single center, retrospective, observational study.Interventional pain medicine · 2025Article
- Tripod-Fix device for the treatment of painful osteoporotic vertebral compression fractures.Scientific reports · 2024Article
- The role of kyphoplasty and expandable intravertebral implants in the acute treatment of traumatic thoracolumbar vertebral compression fractures: a systematic review.EFORT open reviews · 2024Article
- Hybrid kyphoplasty with short-versus intermediate- and long-segment pedicle screw fixations for the management of thoracolumbar burst fractures.BMC musculoskeletal disorders · 2024Article
- Vertebral augmentation: an overview.Skeletal radiology · 2023Review
- "Double Cross Sign" Could Be an Indicator of an Adequate Amount of Bone Cement in Kyphoplasty with the SpineJack System: A Retrospective Study.Diagnostics (Basel, Switzerland) · 2022Article
- Cement augmentation for treatment of high to mid-thoracic osteoporotic compression fractures, high-viscosity cement percutaneous vertebroplasty versus balloon kyphoplasty.Scientific reports · 2022Article
- INTRAVERTEBRAL EXPANDABLE IMPLANTS IN THORACOLUMBAR VERTEBRAL COMPRESSION FRACTURES.Acta ortopedica brasileira · 2022Article
- Balloon Kyphoplasty vs Vertebroplasty: A Systematic Review of Height Restoration in Osteoporotic Vertebral Compression Fractures.Journal of pain research · 2022Review
- Effects of distribution of bone cement on clinical efficacy and secondary fracture after percutaneous kyphoplasty for osteoporotic vertebral compression fractures.Frontiers in surgery · 2022Article
- Expandable Intravertebral Implants: A Narrative Review on the Concept, Biomechanics, and Outcomes in Traumatology.Cureus · 2021Review
- Kyphoplasty with intravertebral reduction devices associated with better height restoration and greater kyphosis correction than kyphoplasty with balloons.Scientific reports · 2021Article
- Vertebral augmentation with spinal implants: third-generation vertebroplasty.Neuroradiology · 2020Review
- Balloon Kyphoplasty Complication: A Case of a Lodged Balloon Within the Vertebral Body.Cureus · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledClinical 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.
introductionIn 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.
methodsThirty 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.
resultsSpineJack® 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).
conclusionsThis 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.
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