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

Percutaneous Injection of Strontium Containing Hydroxyapatite Versus Polymethacrylate 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.

Study Overview

• Status: Completed
• Conditions: Thoracic Fracture; Lumbar Fracture
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 38

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 53 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult female patients that had a single, severely (>40%) compressed A2 and A3/AO-type thoracolumbar (T10-L3) fracture, without any serious concomitant injuries.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital of Patras
• Collaborators: St. Andrew's General Hospital, Patras, Greece
• Investigators: Principal Investigator: Vasileios Syrimpeis, MD, General Hospital of Patras

Publications and helpful links

General Publications

• Korovessis P, Mpountogianni E, Syrimpeis V, Baikousis A, Tsekouras V. Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate Plus Short-Segment Pedicle Screw Fixation for Traumatic A2- and A3/AO-Type Fractures in Adults. Adv Orthop. 2018 Mar 5;2018:6365472. doi: 10.1155/2018/6365472. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2013
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 11, 2018
• First Posted (ACTUAL): February 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 11, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: PEEK; PMMA; Thoracolumbar fractures; KIVA
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2018NEOGEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only data published in Scientific Journal Publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No