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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03431519
Acronym
NEOGEL
Enrollment
38
Registered
2018-02-13
Start date
2013-04-30
Completion date
2016-02-29
Last updated
2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Fracture, Thoracic Fracture

Keywords

Thoracolumbar fractures, PMMA, KIVA, PEEK

Brief summary

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

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.

Interventions

PROCEDUREVP

Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate plus Short Segment Pedicle Screw Fixation

Sponsors

St. Andrew's General Hospital, Patras, Greece
CollaboratorOTHER
University Hospital of Patras
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
38 Years to 53 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS)33 monthsUnits on VAS scale (0-10)

Secondary

MeasureTime frameDescription
Segmental kyphosis angle (SKA)33 monthsAngle degrees measured on Xrays
Vertebral body height ratios (VBHr)33 monthsPercentage measured on Xrays
Spinal canal encroachment (SCE)33 monthsPercentage measured on CT scans
Cement leakage33 monthsYes or no (Boolean value)
Sr-HA resorption33 monthsYes or no (Boolean value)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026