Spots Global Cancer Trial Database for OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

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Trial Identification

Brief Title: OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

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

Study ID: NCT01613144

Conditions

Osteoporosis

Poor Bone Quality

Interventions

OsseoScrew Spinal Fixation System

Study Description

Brief 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.