Clinical trial NCT03431519: Percutaneous Injection Plus Short Segment Pedicle Screw Fixation for Traumatic A2 and A3 AO-type Fractures in Adults
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Fracture
Thoracic Fracture
Keywords: Thoracolumbar fractures
PMMA
KIVA
PEEK
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
Collaborators: name: St. Andrew's General Hospital, Patras, Greece
First posted: 2018-02-13
Enrollment: 38
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 53
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 33 months
Secondary outcomes:
measure: Segmental kyphosis angle (SKA)
timeFrame: 33 months
measure: Vertebral body height ratios (VBHr)
timeFrame: 33 months
measure: Spinal canal encroachment (SCE)
timeFrame: 33 months
measure: Cement leakage
timeFrame: 33 months
measure: Sr-HA resorption
timeFrame: 33 months
Other outcomes:
Locations:
Study officials:
affiliation: General Hospital of Patras
name: Vasileios Syrimpeis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.