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

Completed

• Conditions: Thoracic Fracture; Lumbar Fracture
• Interventions: Procedure: VP

• Registration Number: NCT03431519
• Lead Sponsor: University Hospital of Patras

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2018-01-29
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-11
• Last Update Submitted: 2018-02-11
• Study First Posted: 2018-02-13
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	VP	The subjects received VP with PEEK and Sr-HA
Group B	VP	The subjects received VP with PEEK and PMMA

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	33 months	Units on VAS scale (0-10)

Secondary Outcome Measures

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