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

NCT03431519 | Completed

• 1 other identifier: 2018NEOGEL
• Study Type: observational
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Fracture; Thoracic Fracture

Keywords

Thoracolumbar fractures; PMMA; KIVA; PEEK

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  Units on VAS scale (0-10)

  33 months

Secondary Outcomes (5)

• Segmental kyphosis angle (SKA)

  33 months

• Vertebral body height ratios (VBHr)

  33 months

• Spinal canal encroachment (SCE)

  33 months

• Cement leakage

  33 months

• Sr-HA resorption

  33 months

Study Arms (2)

Group A

The subjects received VP with PEEK and Sr-HA

Procedure: VP

Group B

The subjects received VP with PEEK and PMMA

Procedure: VP

Interventions

VP PROCEDURE

Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate plus Short Segment Pedicle Screw Fixation

Also known as: Vertebroplasty

Group A; Group B

Eligibility Criteria

• Age: 38 Years - 53 Years
• Gender Eligibility Details: Female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• One single, severely (\>40%) compressed A2 and A3/AO-type thoracolumbar (T10-L3) fracture
• No other serious concomitant injuries

You may not qualify if:

• Polytrauma
• Neurologic impairment
• Spinal deformity
• Known malignancy
• Previous fracture or surgery in the same or adjacent vertebrae

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 29692935 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

Vertebroplasty

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Vasileios Syrimpeis, MD

  General Hospital of Patras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 13, 2018
• Study Start: April 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share