OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01613144
Verified January 2016 by Alphatec Spine, Inc.. Recruitment status was: Active, not recruiting
This is an Open-label, prospective, randomized, multi-center post-market study.
Condition or disease
OsteoporosisPoor Bone Quality
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
150 skeletally mature study subjects with spinal instability and osteopenia will be enrolled in the study. Subjects will be randomized 1:1 to the OsseoScrew or the control group.
≥ 18 years of age
Spinal instability or deformity requiring fusion with instrumentation
Osteopenia defined as (T-Score of less than -1.0)
No response to nonoperative treatment modalities preceding enrollment.
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
Active systemic or local infection
A life expectancy less than the study duration
Currently an alcohol, solvent, or drug abuser
Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements
History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2)