CompletedNot Applicable

OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

Belgium, Germany94 participantsStarted 2012-05

Plain-language summary

The purpose of this clinical investigation was to collect clinical evidence of the safety and efficacy of the OsseoScrew System. The OsseoScrew System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The study was designed to compare the safety and efficacy of OsseoScrew compared to any other commercially available fenestrated pedicle screw system augmented with PMMA for posterior spinal fixation after surgical correction of spinal deformity or pathology.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥ 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

Exclusion criteria

✕. Active systemic or local infection
✕. A life expectancy less than the study duration
✕. Autoimmune disorders
✕. 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)

What they're measuring

Safety Endpoint: Rate of device-related or PMMA-related complications

Timeframe: 24 months

Efficacy Endpoint: Successful radiographic fusion

Timeframe: 24 months

Trial details

NCT IDNCT01613144

SponsorAlphatec Spine, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-02-12

View on ClinicalTrials.gov More Osteoporosis trials