Overview

This trial is active, not recruiting.

Conditions osteoporosis, poor bone quality
Sponsor Alphatec Spine, Inc.
Start date May 2012
End date February 2017
Trial size 90 participants
Trial identifier NCT01613144, REC-000784

Summary

This is an Open-label, prospective, randomized, multi-center post-market study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Compare complication rates
time frame: Record adverse events until the 2 year time point

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. ≥ 18 years of age 2. Spinal instability or deformity requiring fusion with instrumentation 3. Osteopenia defined as (T-Score of less than -1.0) 4. No response to nonoperative treatment modalities preceding enrollment. 5. Subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study and to return for scheduled follow-up evaluations Exclusion Criteria: 1. Active systemic or local infection 2. A life expectancy less than the study duration 3. Autoimmune disorders 4. Currently an alcohol, solvent, or drug abuser 5. Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements 6. History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2)

Additional Information

Official title Expandable Pedicle Screws Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (PMMA): Complications and Clinical Outcomes in Patients With Osteoporosis or Poor Bone Quality
Description To collect clinical evidence of safety and efficacy of the OsseoScrew Spinal Fixation System versus fenestrated pedicle screws augmented with polymethylmethacrylate (PMMA) in patients with Osteoporosis or Poor Bone Quality
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Alphatec Spine, Inc..