Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation
Primary Purpose
Vertebral Body Fracture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vertebroplasty
Cavuplasty
Sponsored by
About this trial
This is an interventional treatment trial for Vertebral Body Fracture focused on measuring cement leakage, cement augmentation, vertebral body fracture, vertebral cavity, vertebroplasty
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Vertebroplasty
Cavuplasty
Arm Description
This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body)
This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement)
Outcomes
Primary Outcome Measures
CT-Scan evaluation
Number of Cement Extravasation in each Vertebral Body
Secondary Outcome Measures
Visual Analogue Scale
Scores range from 0 (no pain) to 10 (worst possible pain)
Full Information
NCT ID
NCT02557113
First Posted
September 20, 2015
Last Updated
September 21, 2015
Sponsor
Mohammad ARAB MOTLAGH
1. Study Identification
Unique Protocol Identification Number
NCT02557113
Brief Title
Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation
Official Title
Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohammad ARAB MOTLAGH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Body Fracture
Keywords
cement leakage, cement augmentation, vertebral body fracture, vertebral cavity, vertebroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vertebroplasty
Arm Type
Active Comparator
Arm Description
This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body)
Arm Title
Cavuplasty
Arm Type
Experimental
Arm Description
This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement)
Intervention Type
Procedure
Intervention Name(s)
Vertebroplasty
Intervention Description
Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement
Intervention Type
Procedure
Intervention Name(s)
Cavuplasty
Intervention Description
Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection
Primary Outcome Measure Information:
Title
CT-Scan evaluation
Description
Number of Cement Extravasation in each Vertebral Body
Time Frame
One week
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Scores range from 0 (no pain) to 10 (worst possible pain)
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Arab Motlagh, MD
Organizational Affiliation
Department of Orthopaedic Surgery University Hospital Frankfurt
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation
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