OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA) bone cement.
The purpose of the study is to provide reasonable assurance on safety and effectiveness of the OsseoFix Spinal Fracture Reduction System for market release approval in the US.
This investigational device is intended to restore biomechanical integrity to a vertebral body that has suffered a painful compression fracture in the thoracic or lumbar spine between levels T6 and L5.
Vertebral Compression Fractures
Device: OsseoFix Spinal Fracture Reduction System
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Safety and Effectiveness of the OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture|
- Reduction of back pain at 12-m f/u by ≥ 20mm from baseline measured by VAS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Reduction in functional disability at 12m f/u by ≥ 15 pnts from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- No device related surgical intervention/retreatment at treated level during 12m [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change VAS at 12m [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change ODI at 12m [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Proportion of subject free device related surgical intervention during 12m [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Any cement extravasation before discharge [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Any new VCF during 12m [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change neuro status at 12m f/u [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Vertical height and spine alignment by x-ray at 12m f/u [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- QOL improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||July 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Device: OsseoFix Spinal Fracture Reduction System
All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
This is a prospective, multi-center clinical study designed to evaluate safety and effectiveness of the OsseoFix Spinal Fracture Reduction System used with PMMA bone cement relative to the clinical expectations for treatment of vertebral compression fractures (VCFs). The study will be conducted at up to 15 investigational centers in the United States in 115 (up to 125) subjects with one or two vertebral compression fractures between levels T6 and L5 implanted with the investigational device(s).
Baseline screening will be completed to determine eligible subjects. VCFs will be confirmed by magnetic resonance imaging (MRI), or by a CT / bone scan. These diagnostic tests will be utilized to confirm that there are no retropulsed bone fragments. Subjects who meet all inclusion criteria and do not have any exclusion criteria will be scheduled to receive the OsseoFix Spinal Fracture Reduction System.
Subjects that are enrolled will be implanted with the OsseoFix Spinal Fracture Reduction System through a postero-lateral approach to the anterior vertebral body using instruments specifically designed for this procedure.
Radiographs will be taken at each follow-up visit, including baseline and post-operatively. Subject's perception of pain will be assessed using the Visual Analogue Scale (VAS). Functional outcomes will be measured using the Oswestry Disability Index (ODI) and Short Form- 36 (SF-36) questionnaires as well as their neurologic status. The VAS, ODI, SF-36 and neurologic status will be measured at baseline, 4-week, 3-month, 6-month and 12-month follow-up visits. Overall patient-satisfaction will be evaluated at all post-implant scheduled follow-up visits. Adverse event will be the recorded in all scheduled and non-scheduled visits.
The endpoint analysis will be performed and submitted when all implanted subjects have completed their 12-months follow-up.
|United States, California|
|La Jolla, California, United States, 92037|
|United States, Colorado|
|Boulder Neurosurgery Associates|
|Boulder, Colorado, United States, 80304|
|South Denver Neurosurgery|
|Littleton, Colorado, United States, 80122|
|United States, Florida|
|Jacksonville, Florida, United States, 32207|
|United States, Georgia|
|Southwestern Orthopedic Center|
|Savannah, Georgia, United States, 31405|
|United States, Illinois|
|SIU Phyysicians and Surgeons Division of Orthopaedics and Rehabilitation|
|Springfield, Illinois, United States, 62702|
|United States, Kentucky|
|Jewish Hospital for Advanced Medicine|
|Louisville, Kentucky, United States, 40202|
|United States, Oklahoma|
|Clinical Radiology of Oklahoma|
|Edmond, Oklahoma, United States, 73034|
|United States, Oregon|
|NeuroSpine Institute, LLC|
|Eugene, Oregon, United States, 97401|
|United States, Pennsylvania|
|Orthopaedic Associates of the Greater Lehigh Valley Easton Hospital|
|Easton, Pennsylvania, United States, 18045|
|United States, Tennessee|
|Neurospine Solutions, PC|
|Bristol, Tennessee, United States, 37620|
|Principal Investigator:||James Yue, MD||Yale University|
|Principal Investigator:||Daniel Bennett, MD||Integrative Treatment Centers|