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

Sponsor
University Hospital of Patras (Other)
Overall Status
Completed
CT.gov ID
NCT03431519
Collaborator
St. Andrew's General Hospital, Patras, Greece (Other)
38
Enrollment
34
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: VP

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.

Study Design

Study Type:
Observational
Actual Enrollment :
38 participants
Observational Model:
Other
Time Perspective:
Retrospective
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
Actual Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Group A

The subjects received VP with PEEK and Sr-HA

Procedure: VP
Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate plus Short Segment Pedicle Screw Fixation
Other Names:
  • Vertebroplasty

    		•
    Group B

    The subjects received VP with PEEK and PMMA

    Procedure: VP
    Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate plus Short Segment Pedicle Screw Fixation
    Other Names:
  • Vertebroplasty

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analog Scale (VAS) [33 months]

      Units on VAS scale (0-10)

    Secondary Outcome Measures

    1. Segmental kyphosis angle (SKA) [33 months]

      Angle degrees measured on Xrays

    2. Vertebral body height ratios (VBHr) [33 months]

      Percentage measured on Xrays

    3. Spinal canal encroachment (SCE) [33 months]

      Percentage measured on CT scans

    4. Cement leakage [33 months]

      Yes or no (Boolean value)

    5. Sr-HA resorption [33 months]

      Yes or no (Boolean value)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    38 Years to 53 Years
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Vasileios Syrimpeis, MD, General Hospital of Patras

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vasileios Syrimpeis, Orthopaedic Surgeon, University Hospital of Patras
    ClinicalTrials.gov Identifier:
    NCT03431519
    Other Study ID Numbers:
    • 2018NEOGEL
    First Posted:
    Feb 13, 2018
    Last Update Posted:
    Feb 13, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vasileios Syrimpeis, Orthopaedic Surgeon, University Hospital of Patras
    Thoracolumbar fractures
    PMMA
    KIVA
    PEEK
    Additional relevant MeSH terms:
    Fractures, Bone

    Study Results

    No Results Posted as of Feb 13, 2018