Trial reportPloS one2013
Percutaneous Stabilization System Osseofix® for Treatment of Osteoporotic Vertebral Compression Fractures - Clinical and Radiological Results after 12 Months.
Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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
11 citing papers in PubMed.
- Cementless fixation of osteoporotic VCFs using titanium mesh implants (OsseoFix): preliminary results.BioMed research international · 2014Trial
- Mechanical augmentation for vertebral compression fractures: A scoping review.Interventional pain medicine · 2026Review
- Biomaterials for vertebral body repair: interior augmentation and total replacement-a literature review of bone fusion outcomes in clinical studies.Journal of spine surgery (Hong Kong) · 2026Review
- Technical Limitations and Implant Developments in Percutaneous Kyphoplasty for Osteoporotic Vertebral Compression Fractures.Orthopaedic surgery · 2026Review
- [Primary development of visual uroflow scale].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2020Article
- Advances in Vertebral Augmentation Systems for Osteoporotic Vertebral Compression Fractures.Pain research & management · 2020Review
- Innovative Spine Implants for Improved Augmentation and Stability in Neoplastic Vertebral Compression Fracture.Medicina (Kaunas, Lithuania) · 2019Review
- Percutaneous stabilization of lumbar spine: a literature review and new options in treating spine pain.The British journal of radiology · 2016Review
- Third-generation percutaneous vertebral augmentation systems.Journal of spine surgery (Hong Kong) · 2016Review
- Cementless Titanium Mesh Fixation of Osteoporotic Burst Fractures of the Lumbar Spine Leads to Bony Healing: Results of an Experimental Sheep Model.BioMed research international · 2016Article
- Is the pain visual analogue scale linear and responsive to change? An exploration using Rasch analysis.PloS one · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
designA prospective consecutive cohort study (follow-up study).
objectiveOur study investigated whether implantation of an expandable titanium mesh cage (Osseofix®) is a successful and safe minimally invasive therapy for osteoporotic vertebral compression fractures (VCF). Our experiences, clinical and radiological findings after 12 months follow-up are presented. Kypho- and vertebroplasty are well-established minimally invasive procedures for the treatment of osteoporotic VCF. The main complications associated with both procedures are uncontrolled bone cement leakage. Therefore a suitable alternative has been investigated.
methodsDuring June 2010 to May 2011 24 patients were included with 32 osteoporotic VCF (T6 to L4). All of them were stabilized with the Osseofix® system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA). Clinical and radiological results were evaluated preop., postop. and after 12 months postop. based on the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS), X-ray (Beck Index, Cobb-angle) and CT.
resultsThere was a significant improvement in the mean ODI (70,6% to 30,1%) as well as a significant reduction in pain intensity (VAS) (7,7 to 1,4) after 12 month. The mean kyphotic angle according to Cobb showed significant improvements (11,7° to 10,4°) after 12 months. Postinterventional imaging showed only one case of loss of height in a stabilized vertebral body (3.1%). We saw no changes in posterior vertebral wall or adjacent fractures. Except for one pronounced postoperative hematoma we saw no surgical complications including no cement leakage.
conclusionsStabilization of symptomatic osteoporotic VCF with Osseofix® system is a safe and effective procedure, even in fractures with posterior wall involvement. The clinical mid-term results are good at a very low complication rate. The Osseofix® system is an interesting alternative to the established procedures of cement augmentation.
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