Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2019
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.
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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 33 papers, 2 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.
- Optimal management for osteoporotic vertebral compression fractures: a network meta-analysis.Journal of orthopaedic surgery and research · 2025Pooled it
- 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
- 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
- Efficacy and safety of vertebral augmentation techniques in patients with osteoporotic vertebral compression fractures: A single center, retrospective, observational study.Interventional pain medicine · 2025Article
- Surgical treatment of post-traumatic vertebral osteonecrosis including intravertebral expansive implants-clinical, functional and imaging outcomes and a center experience over 7 years.Journal of spine surgery (Hong Kong) · 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
- A Toolbox of Bone Consolidation for the Interventional Radiologist.Cardiovascular and interventional radiology · 2023Review
- Clinical Outcomes and Safety Comparison of Vertebroplasty, Balloon Kyphoplasty, and Vertebral Implant for Treatment of Vertebral Compression Fractures.AJNR. American journal of neuroradiology · 2023Article
- Implant removal after short percutaneous pedicle fixation associated with SpineJackArchives of orthopaedic and trauma surgery · 2023Article
- Percutaneous Vertebral Reconstruction (PVR) Technique of Pathological Compression Fractures: An Innovative Combined Treatment of Microwave Ablation, Bilateral Expandable Titanium SpineJack Implants Followed by Vertebroplasty.Journal of clinical medicine · 2023Article
- Sagittal correction after short percutaneous fixation for thoracolumbar compression fractures: comparison of the combination of SpineJack® kyphoplasty and fractured vertebra screw fixation.International orthopaedics · 2023Article
- Spinal artery syndrome following kyphoplasty in the setting of a non-compressive extradural cement extravasation: a case report.Spinal cord series and cases · 2023Article
- Biomechanical evaluation of a novel minimally invasive pedicle bone cement screw applied to the treatment of Kümmel's disease in porcine vertebrae.Frontiers in bioengineering and biotechnology · 2023Article
- EXPANDABLE INTRAVERTEBRAL IMPLANTS IN POST-TRAUMATIC VERTEBRAL NECROSIS - NEW CLASSIFICATION SUGGESTION.Acta ortopedica brasileira · 2023Review
- Re-expansion of vertebral compression fractures in patients with multiple myeloma with percutaneous vertebroplasty using spinejack implants: a preliminary and retrospective study.Frontiers in surgery · 2023Article
- Innovative minimally invasive implants for osteoporosis vertebral compression fractures.Frontiers in medicine · 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
- Robot-Assisted Versus Fluoroscopy-Assisted Kyphoplasty in the Treatment of Osteoporotic Vertebral Compression Fracture: A Retrospective Study.Global spine journal · 2022Article
- Numerical Comparison of Restored Vertebral Body Height after Incomplete Burst Fracture of the Lumbar Spine.Journal of personalized medicine · 2022Article
Corrections and comments
- Erratum issued
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This pilot monocenter study in 30 patients with painful osteoporotic vertebral compression fractures compared two vertebral augmentation procedures. Over a 3-year post-surgery follow-up, pain/disability/quality of life remained significantly improved with both balloon kyphoplasty and SpineJack® techniques, but the latter allowed better vertebral body height restoration/kyphosis correction.
introductionPatient follow-up rarely exceed 2 years in trials comparing vertebral augmentation procedures for the treatment of painful osteoporotic vertebral compression fractures (VCFs). This pilot, investigator-initiated, prospective study aimed to compare long-term results of SpineJack® (SJ) and balloon kyphoplasty (BKP). Preliminary results showed that SJ resulted in a better restoration of vertebral heights and angles, maintained over 12 months.
methodsThirty patients were randomized to SJ (n = 15) or BKP (n = 15). Clinical endpoints were analgesic consumption, back pain intensity (visual analog scale (VAS)), the Oswestry Disability Index (ODI), and quality of life (EQ-VAS score). They were recorded preoperatively, at 5 days (except EQ-VAS), 1, 3, 6, 12, and 36 months post-surgery. Spine X-rays were taken 48 h prior to the procedure and 5 days, 6, 12, and 36 months after.
resultsClinical improvements were observed with both procedures over the 3-year period without significant inter-group differences, but the final mean EQ-5D
conclusionsIn this study, both techniques displayed very good long-term clinical efficiency and safety in patients with osteoporotic VCFs. Over the 3-year follow-up, vertebral body height restoration/kyphosis correction was better with the SpineJack® procedure.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.