Höhenrekonstruktion und -erhalt osteoporotischer Wirbelkörperkompressionsfrakturen – Eine biomechanische Vergleichsstudie der Standard Ballon-Kyphoplastie zur Radiofrequenz-Kyphoplastie an einem Kadaver-Modell
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Philipps-Universität Marburg
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Abstract
Osteoporosis and osteoporotic vertebral body fractures represent a significant health and
socioeconomic problem with increasing potential in the context of demographic change and the
increasingly aging population. The underlying osteoporosis is characterized by a pathological
decrease in bone density and an associated reduction in bone stability. The etiology is
multifactorial. Identified risk factors are age and female gender. According to estimates, every
fourth woman over the age of 50 in Germany is affected by osteoporosis. The lifetime risk of
suffering an osteoporotic fracture is about 40-50% for women, depending on gender. The
probability of suffering another fracture after a previous fracture is estimated to be 4-5 times
higher in those affected than in the general population. Vertebral body fractures account for about
15% of all osteoporotic fractures and are mostly compression fractures of various degrees because
of low-energy trauma, which would not lead to a fracture in a healthy bone. The literature assumes
an increase in the incidence of osteoporotic fractures of about 40% by 2030.
Over the last decades, multimodal therapy concepts have been developed which are regularly
updated. These include standardized diagnostics as well as conservative and surgical therapy
options, which ultimately aim at an individual and interdisciplinary therapy concept. In this
context, minimally invasive vertebral cement augmentations represent the most important
surgical therapy options. The Vertebroplasty and the Balloon-Kyphoplasty have become widely
established over the decades due to their extensive availability, good area-wide expertise, and
good therapeutic results with a relatively low complication rate. Nevertheless, there is the
possibility of further improving the minimally invasive procedures, especially with regard to
minimizing the serious complications, such as cement extravasation, with comparable therapeutic
results and preserving intact tissue. As a result, radiofrequency kyphoplasty was developed by the
DFine company, which was intended to represent an alternative to the established procedures
using smaller amounts of highly viscous bone cement via a unipedicular access and targeted,
economical cavity shaping.
The aim of our work was the quantitative comparison of the Radiofrequency-Kyphoplasty to the
established Balloon-Kyphoplasty with regard to their results in height Restoration and height
preservation of stable osteoporotic vertebral compression fractures (wedge fractures) of the
classification Genant II-III in an in vitro cadaver model. In addition, we wanted to implement a
procedure for generating standardized vertebral compression fractures with a 30% reduction in
height.
For this purpose, we had two fresh-frozen donor spines from two Caucasian women, 75 and 73
years old respectively, with no known malignancy, previous vertebral body fractures and known
high-grade osteoporosis. An initial DXA of both Specimens showed a T-score of -7 and -7.4 and
thus the presence of severe osteoporosis. A CT performed prior to the experiment confirmed the
suitability of the Specimens for our experimental setup. In each case, the vertebral bodies T6 to
L5 and a single L6 were selected, individually dissected and prepared down to the bony structures
and individually enclosed in a plastic polymer on the cover and base plates. This was followed by
randomization into two groups according to a matched-pair design. The fractures were generated
on each individual vertebral body Specimen via continuous axial loading under 100 N minimum
applied load in the loading machine until the desired wedge fracture was achieved with a 30%
reduction in height. This was achieved satisfactorily for all preparations with no statistical
difference between the two groups. The operation was carried out as planned with a base load of
100 N and in compliance with the manufacturer's specifications on 12 vertebral bodies in the BKP
group and 13 vertebral bodies in the RFK group. A good height reconstruction could be achieved
in both groups with no statistical difference between the two groups. Subsequently, all Specimens
were loaded in a loading machine to emulate a physiological post-operative period of 3 months
according to a fixed, standardized test protocol (100-600, 1 Hz, 100,000 cycles). The results were
comparable to those of clinical studies and showed no statistical difference between the test
groups. What was striking was the statistically significant lower amount of bone cement used in
the RFK group, which corresponds to the surveys of clinical studies.
With our fracture model, we have succeeded in generating standardized compression fractures on
an osteoporotic vertebral body in an in vitro cadaver model. Our study was able to show in vitro
that the Radiofrequency-Kyphoplasty is at least an equivalent alternative to the Balloon-Kyphoplasty
in regard to height reconstruction and height preservation of osteoporotic vertebral
compression fractures, while at the same time requiring significantly less cement volume. The
latter could represent an advantage of RFK over BKP with regard to the complication profile in
cement extravasation, interdigitation, fracture healing and the occurrence of subsequent fractures.
Due to the use of a cadaver model and only an approximate simulation of physiological
conditions, our results can only be transferred to an in vivo situation to a limited extent, despite
good quantitative comparability. Nevertheless, our study provides valid evidence of a possible
superiority of RFK, which should be further determined in large clinical studies.
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Created: 2023Issued: 2023-03-09Updated: 2023-03-09
Faculty
Medizin
Publisher
Philipps-Universität Marburg
Language
ger
Data types
DoctoralThesis
Keywords
Radiofrequenz-KyphoplastieKadaver-ModellHöhenrekonstruktionBiomechanische StudieHöhenerhaltBallon-KyphoplastieOsteoporose
DDC-Numbers
610
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Rotsch, Gil Nio: Höhenrekonstruktion und -erhalt osteoporotischer Wirbelkörperkompressionsfrakturen – Eine biomechanische Vergleichsstudie der Standard Ballon-Kyphoplastie zur Radiofrequenz-Kyphoplastie an einem Kadaver-Modell. : Philipps-Universität Marburg 2023-03-09. DOI: https://doi.org/10.17192/z2023.0148.
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This item has been published with the following license: In Copyright