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OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

2014-08-27 03:19:56 | BioPortfolio

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Vertebral Compression Fractures

Intervention

OsseoFix Spinal Fracture Reduction System

Location

Scripps
La Jolla
California
United States
92037

Status

Recruiting

Source

Alphatec Spine, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:56-0400

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Medical and Biotech [MESH] Definitions

Crumbling or smashing of cancellous BONE by forces acting parallel to the long axis of bone. It is applied particularly to vertebral body fractures (SPINAL FRACTURES). (Blauvelt and Nelson, A Manual of Orthopedic Terminology, 1994, p4)

Acute and chronic conditions characterized by external mechanical compression of the SPINAL CORD due to extramedullary neoplasm; EPIDURAL ABSCESS; SPINAL FRACTURES; bony deformities of the vertebral bodies; and other conditions. Clinical manifestations vary with the anatomic site of the lesion and may include localized pain, weakness, sensory loss, incontinence, and impotence.

Fractures of the skull which may result from penetrating or nonpenetrating head injuries or rarely BONE DISEASES (see also FRACTURES, SPONTANEOUS). Skull fractures may be classified by location (e.g., SKULL FRACTURE, BASILAR), radiographic appearance (e.g., linear), or based upon cranial integrity (e.g., SKULL FRACTURE, DEPRESSED).

A surgical procedure that entails removing all (laminectomy) or part (laminotomy) of selected vertebral lamina to relieve pressure on the SPINAL CORD and/or SPINAL NERVE ROOTS. Vertebral lamina is the thin flattened posterior wall of vertebral arch that forms the vertebral foramen through which pass the spinal cord and nerve roots.

Broken bones in the vertebral column.

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