NCT01613144

OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

Expandable Pedicle Screws Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (PMMA): Complications and Clinical Outcomes in Patients With Osteoporosis or Poor Bone Quality

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Alphatec Spine, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a randomized, open-label, controlled, multi-center study in which patients were randomized in a 1:1 ratio to receive either the OsseoScrew or any commercially available fenestrated screw augmented with polymethylmethacrylate (PMMA) (Control group) for posterior spinal fixation after surgical correction of spinal deformity or pathology. The study was planned to include up to 150 skeletally mature patients with spinal instability and osteopenia at up to 10 sites. Patients were to return postoperatively at 6 weeks (± 2 weeks) and at 6, 12, and 24 months (± 2 months) for assessments.

Conditions

• Osteoporosis
• Poor Bone Quality

Interventions

Type	Name	Description
DEVICE	OsseoScrew Spinal Fixation System	Surgical intervention

Timeline

• Start date: 2012-05-01
• Primary completion: 2017-02-12
• Completion: 2017-11-08
• First posted: 2012-06-07
• Last updated: 2022-02-25

Locations

10 sites across 5 countries: Belgium, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated device study