Creation of a Small Cavity Reduces the Rate of Cement Lea... | NCT02557113

Studies
Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation

NCT02557113

Sponsor

Mohammad ARAB MOTLAGH

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

36Actual

Phase

Not Applicable

Conditions

Vertebral Body Fracture

Interventions

Vertebroplasty
Cavuplasty

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

Sep 2015

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

Jan 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Sep 20, 2015

First Submission Date that Met QC Criteria

Sep 21, 2015

First Posted Date

Sep 23, 2015Estimated

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

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. Investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vertebroplasty	Active Comparator	This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body)	Procedure: Vertebroplasty
Cavuplasty	Experimental	This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement)	Procedure: Cavuplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vertebroplasty	Procedure	Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement	Vertebroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CT-Scan evaluation	Number of Cement Extravasation in each Vertebral Body	One week

Secondary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale	Scores range from 0 (no pain) to 10 (worst possible pain)	3 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification

Exclusion Criteria:

More Than 2 Vertebral Body Fractures
Fractures of Vertebral Body Based on Malignancy
Previous Spinal Operation
Spinal Infection
Spinal Deformity (scoliosis)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammad Arab Motlagh, MD	Department of Orthopaedic Surgery University Hospital Frankfurt	Study Director

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054854	Vertebroplasty

Ancestor Terms

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

Browse Leaves

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Browse Branches

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