OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)
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ClinicalTrials.gov Identifier: NCT01613144
Recruitment Status : Unknown
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
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
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)