Clinical Trial: OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Evaluation of Safety and Effectiveness of the OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

Brief Summary:

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.


Detailed Summary:

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.

  • Reduction of back pain at 12-m f/u by ≥ 20mm from baseline measured by VAS [ Time Frame: 12 months ]
  • Reduction in functional disability at 12m f/u by ≥ 15 pnts from baseline [ Time Frame: 12 months ]
  • No device related surgical intervention/retreatment at treated level during 12m [ Time Frame: 12 months ]


    • Original Primary Outcome:

    • Reduction of back pain at 6-m f/u by ≥ 20mm from baseline measured by VAS [ Time Frame: 6 months ]
    • Reduction in functional disability at 6m f/u by ≥ 15 pnts from baseline [ Time Frame: 6 months ]
    • No device related surgical intervention/retreatment at treated level during 6m [ Time Frame: 6 months ]


    Current Secondary Outcome:

    • Change VAS at 12m [ Time Frame: 12 months ]
    • Change ODI at 12m [ Time Frame: 12 months ]
    • Proportion of subject free device related surgical intervention during 12m [ Time Frame: 12 months ]
    • Any cement extravasation before discharge [ Time Frame: 12 months ]
    • Any new VCF during 12m [ Time Frame: 12 months ]
    • Change neuro status at 12m f/u [ Time Frame: 12 months ]
    • Vertical height and spine alignment by x-ray at 12m f/u [ Time Frame: 12 months ]
    • QOL improvement [ Time Frame: 12 months ]


    Original Secondary Outcome:

    • Change VAS at 6m [ Time Frame: 6 months ]
    • Change ODI at 6m [ Time Frame: 6 months ]
    • Proportion of subject free device related surgical intervention during 6m [ Time Frame: 6 months ]
    • Any cement extravasation before discharge [ Time Frame: 6 months ]
    • Any new VCF during 6m [ Time Frame: 6 months ]
    • Change neuro status at 6m f/u [ Time Frame: 6 months ]
    • Vertical height and spine alignment by x-ray at 6m f/u [ Time Frame: 6 months ]
    • QOL improvement [ Time Frame: 6 months ]


    Information By: Alphatec Spine, Inc.

    Dates:
    Date Received: August 17, 2009
    Date Started: August 2009
    Date Completion:
    Last Updated: January 7, 2014
    Last Verified: January 2014