Lumbar Fracture Clinical Trial
Official title:
Percutaneous Injection of Strontium Containing Hydroxyapatite Versus Polymethacrylate Plus Short Segment Pedicle Screw Fixation for Traumatic A2 and A3 AO-type Fractures in Adults
The aim of this study was to examine the short- to medium-term efficacy of percutaneous vertebral body reconstruction by vertebral body augmentation with Sr-HA paste plus short-segment pedicle screw fixation in fresh fractures, as well as to evaluate Sr-HA resorption/substitution. The hypotheses tested in this study were as follows: 1) whether Sr-HA is equivalent to PMMA for restoring the fractured thoracolumbar vertebral body, 2) whether leakage of Sr-HA is less than that of PMMA, and 3) whether Sr-HA is completely resorbed and replaced by cancellous bone.
Introduction Polymethacrylate (PMMA) is commonly used in vertebroplasty and balloon
kyphoplasty, but its use has been associated with complications. This study tests three
hypotheses: 1) whether strontium hydroxyapatite (Sr-HA) is equivalent to PMMA for restoring
thoracolumbar vertebral body fractures, 2) if incidence of PMMA leakage is similar to that of
Sr-HA leakage, and 3) whether Sr-HAis resorbed and substituted by new vertebral bone.
Materials and Methods Two age- and sex-matched groups received short percutaneous pedicle
screw fixation plus PEEK implant (Kiva, VCF Treatment System, Benvenue Medical, Santa Clara,
CA, USA) filled with either Sr-HA (Group A) or PMMA (Group B) after A2- and A3/AO-type
thoracolumbar vertebral body fractures. Visual Analog Scale (VAS) score and imaging
parameters, which included segmental kyphosis angle (SKA), vertebral body height ratios
(VBHr), spinal canal encroachment (SCE), bone cement leakage, and Sr-HA resorption, were
compared between the two groups.
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