OsseoFix® for treatment of painful osteoporotic vertebral compression fractures

Not Applicable

• Conditions: M80.08; M80.88

• Registration Number: DRKS00008833
• Lead Sponsor: Klinik für Orthopädie und Orthopädische Chirurgie Universitätsmedizin Greifswald

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-02-01
• Study Start: 2015-06-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

proven symptomatic lumbar or thoracic fresh osteoporotic vertebral fracture (A1.1-1.3 and A3.1) and an exhausted conservative treatment according to the current DVO guidelines

Exclusion Criteria

neurological deficits, due to posterior vertebral edge involvement that caused relevant spinal canal stenosis and known allergies to the contents of the Osseofix® systems or to bone cement

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and radiological evaluation after 12 and 24 months postoperatively. Clinical evaluation by Oswestry Disability Index (ODI) and visual pain analog scale (VAS); imaging postoperative X-ray of relevant spinal with respect to the vertebral and spinal profile

Secondary Outcome Measures

Name	Time	Method
Radiological evaluation with imaging postoperative X-ray of relevant spinal region in two views and postoperative CT and X-ray of relevant spinal region in two views after 12 and 24 months for the evaluation of cementleakage,vertebral redressement, loss of height of the stabilized vertebra and adjacent fracture