Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290862
Status:
UNKNOWN
Last Update Posted:
2008-10-15
First Post:
2006-02-10
Brief Title:
A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis
Sponsor:
Orthovita dba Stryker
Organization:
Orthovita dba Stryker
Study Overview
Official Title:
A Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of CORTOSS Synthetic Cortical Bone Void Filler in Vertebral Augmentation
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Doctors are studying an investigational treatment to be used during the vertebroplasty procedure when treating vertebral compression fractures spine fractures that may help to reduce pain and restore mobility If one has experienced back pain for at least 4 weeks but not longer than 1 year heshe may be eligible to participate
The purpose of this protocol is to describe the methods for the clinical evaluation of Cortoss for vertebroplasty in patients with painful osteoporotic compression fractures
Eligible patients with painful osteoporotic compression fractures of the spine are divided into two groups Each enrolled patient will have the vertebroplasty procedure however one group of patients will have the vertebroplasty procedure using polymethylmethacrylate PMMA a Food and Drug Administration FDA-approved bone cement and the other group of patients will have the vertebroplasty procedure using a relatively new investigational biomaterial called Cortoss
The purpose of this protocol is to describe the methods for the clinical evaluation of Cortoss for vertebroplasty in patients with painful osteoporotic compression fractures
Eligible patients with painful osteoporotic compression fractures of the spine are divided into two groups Each enrolled patient will have the vertebroplasty procedure however one group of patients will have the vertebroplasty procedure using polymethylmethacrylate PMMA a Food and Drug Administration FDA-approved bone cement and the other group of patients will have the vertebroplasty procedure using a relatively new investigational biomaterial called Cortoss
Detailed Description:
This is a prospective multi-center randomized controlled study designed to evaluate the safety and effectiveness of Cortoss Synthetic Cortical Bone Void Filler in vertebral augmentation using the percutaneous vertebroplasty technique Study eligible patients with painful osteoporotic compression fractures will be randomized 21 to vertebroplasty with Cortoss treatment group or PMMA control group respectively Patients will not be told which treatment they will receive single blind study design Safety and effectiveness will be determined by comparing the success rate of the treatment group to the success rate of the control group Secondary endpoints will include Quality of Life Patient satisfaction evaluation of the patients pain and function post-operatively compared to baseline and maintenance of vertebral body height and alignment
For the purposes of this study vertebral augmentation or vertebroplasty is defined as a minimally invasive procedure utilizing manual instruments and radiological guidance to deliver an in-situ polymerizable material to stabilize a collapsed or fractured vertebral body The goal is to alleviate pain caused by the fracture and enhance or prevent further deterioration of function
This multi-center study will evaluate Cortoss for the augmentation of one or two vertebrae fractured as a result of osteoporosis located between and including the levels of the sixth thoracic and the fifth lumbar vertebrae A total of 243 patients will be enrolled at up to 19 sites All subjects must have radiographic evidence of a vertebral body fracture due to osteoporosis After complying with all eligibility criteria subjects will sign an informed consent document and will be randomized into vertebroplasty treatment with Cortoss or PMMA 11 ratio Patients will be followed for at least 24 months and recruitment is expected to take between 9 and 12 months Visits and assessments are planned according to the time and events schedule
For the purposes of this study vertebral augmentation or vertebroplasty is defined as a minimally invasive procedure utilizing manual instruments and radiological guidance to deliver an in-situ polymerizable material to stabilize a collapsed or fractured vertebral body The goal is to alleviate pain caused by the fracture and enhance or prevent further deterioration of function
This multi-center study will evaluate Cortoss for the augmentation of one or two vertebrae fractured as a result of osteoporosis located between and including the levels of the sixth thoracic and the fifth lumbar vertebrae A total of 243 patients will be enrolled at up to 19 sites All subjects must have radiographic evidence of a vertebral body fracture due to osteoporosis After complying with all eligibility criteria subjects will sign an informed consent document and will be randomized into vertebroplasty treatment with Cortoss or PMMA 11 ratio Patients will be followed for at least 24 months and recruitment is expected to take between 9 and 12 months Visits and assessments are planned according to the time and events schedule
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None