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Completed

NCT Number: NCT03431519

Percutaneous Injection 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.

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Key information

Conditions

Lumbar Fracture Fractures, Bone Thoracic Fracture Wounds and Injuries

Age range

38 year–53 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VP

Procedure

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

Other names: Vertebroplasty

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 33 months

    Units on VAS scale (0-10)

Secondary outcomes

  1. Segmental kyphosis angle (SKA)

    Time frame: 33 months

    Angle degrees measured on Xrays

  2. Vertebral body height ratios (VBHr)

    Time frame: 33 months

    Percentage measured on Xrays

  3. Spinal canal encroachment (SCE)

    Time frame: 33 months

    Percentage measured on CT scans

  4. Cement leakage

    Time frame: 33 months

    Yes or no (Boolean value)

  5. Sr-HA resorption

    Time frame: 33 months

    Yes or no (Boolean value)

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Collaborators

  • St. Andrew's General Hospital, Patras, Greece

Registry information

Official study 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

Acronym: NEOGEL

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 13, 2018
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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