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

Lumbar Fracture Clinical Trial

— NEOGEL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431519
• Other study ID #: 2018NEOGEL
• Status: Completed
• Phase: N/A
• First received: January 29, 2018
• Last updated: February 11, 2018
• Start date: April 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2018
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Gender: Female
• Age group: 38 Years to 53 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Lumbar Fracture
• Thoracic Fracture

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Patras	St. Andrew's General Hospital, Patras, Greece

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	Units on VAS scale (0-10)	33 months
Secondary	Segmental kyphosis angle (SKA)	Angle degrees measured on Xrays	33 months
Secondary	Vertebral body height ratios (VBHr)	Percentage measured on Xrays	33 months
Secondary	Spinal canal encroachment (SCE)	Percentage measured on CT scans	33 months
Secondary	Cement leakage	Yes or no (Boolean value)	33 months
Secondary	Sr-HA resorption	Yes or no (Boolean value)	33 months