Percutaneous Injection Plus Short Segment Pedicle Screw Fixation for Traumatic A2 and A3 AO-type Fractures in Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Percutaneous Injection of Strontium Containing Hydroxyapatite Versus Polymethacrylate Plus Short Segment Pedicle Screw Fixation for Traumatic A2 and A3 AO-type Fractures in Adults

Conditions
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Lumbar Fracture, Thoracic Fracture

Intervention / Treatment
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* Procedure: VP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One single, severely (>40%) compressed A2 and A3/AO-type thoracolumbar (T10-L3) fracture No other serious concomitant injuries Exclusion Criteria: Polytrauma Neurologic impairment Spinal deformity Known malignancy Previous fracture or surgery in the same or adjacent vertebrae

Ages Eligible for Study
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Minimum Age: 38 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>The subjects received VP with PEEK and Sr-HA | Procedure: VP<br>* Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate plus Short Segment Pedicle Screw Fixation<br>* Other names: Vertebroplasty;|
| Group B<br>The subjects received VP with PEEK and PMMA | Procedure: VP<br>* Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate plus Short Segment Pedicle Screw Fixation<br>* Other names: Vertebroplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | Units on VAS scale (0-10) | 33 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Segmental kyphosis angle (SKA) | Angle degrees measured on Xrays | 33 months | 
| Vertebral body height ratios (VBHr) | Percentage measured on Xrays | 33 months | 
| Spinal canal encroachment (SCE) | Percentage measured on CT scans | 33 months | 
| Cement leakage | Yes or no (Boolean value) | 33 months | 
| Sr-HA resorption | Yes or no (Boolean value) | 33 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracolumbar fractures, PMMA, KIVA, PEEK