OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)

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.

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)