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OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

NCT00961714 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-04-28

Study results available
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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.

Conditions

  • Vertebral Compression Fractures

Interventions

DEVICE

OsseoFix Spinal Fracture Reduction System

All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.

Sponsors & Collaborators

  • Alphatec Spine, Inc.

    lead INDUSTRY

Principal Investigators

  • James Yue, MD · Yale University

  • Daniel Bennett, MD · Integrative Treatment Centers

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-12-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00961714 on ClinicalTrials.gov