Percutaneous Injection Plus Short Segment Pedicle Screw F... | NCT03431519

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

NCT03431519

Sponsor

University Hospital of Patras

Status

Completed

Last Update Posted

Feb 13, 2018Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Lumbar Fracture
Thoracic Fracture

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013Actual

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jan 29, 2018

First Submission Date that Met QC Criteria

Feb 11, 2018

First Posted Date

Feb 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2018

Last Update Posted Date

Feb 13, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vasileios Syrimpeis, Orthopaedic Surgeon, University Hospital of PatrasPrincipal Investigator

Lead Sponsor

University Hospital of PatrasOTHER

Collaborators

Name	Class
St. Andrew's General Hospital, Patras, Greece	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
VP	Procedure	Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate plus Short Segment Pedicle Screw Fixation	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Scale (VAS)	Units on VAS scale (0-10)	33 months

Secondary Outcomes

Measure	Description	Time Frame
Segmental kyphosis angle (SKA)	Angle degrees measured on Xrays	33 months
Vertebral body height ratios (VBHr)	Percentage measured on Xrays

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

38 Years

Maximum Age

53 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vasileios Syrimpeis, MD	General Hospital of Patras	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29692935	Derived	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.

ID	Term
D060826	Cementoplasty
D019637	Orthopedic Procedures
D013812	Therapeutics
D013514	Surgical Procedures, Operative