Musculoskeletal Diseases

Nutritional and Metabolic Diseases

All Conditions

Symptoms and General Pathology

Osteoporosis

Constriction, Pathologic

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Vasodilator Agents

All Drugs and Chemicals

Polymethyl Methacrylate

Test Product: OsseoScrew Spinal Fixation System

Control Product: Any commercially available fenestrated screw system augmented with PMMA

OsseoScrew Spinal Fixation System

Bita Ghadimi

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.

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.

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

The proportion of patients who were free from device-related or PMMA-related complications leading to revision, supplemental fixation, non-elective removal, or reoperation throughout the study. Complications included, but were not limited to device or PMMA fracture, device or PMMA-related loosening, device or PMMA-related device disassembly, device migration or PMMA extravasation.

Presence of continuous bridging bone across the implant

This is a measure of the patient's self reported permanent functional disability. Each section is scored on a 1-5 scale with 5 representing the greatest disability.

This is a measure of the characteristic or attitude that is believed to range across a continuum of values to measure pain intensity. The range of score is from 0 - 100. The patient marks on the line the point that they feel represents their perception of their current state. A higher score indicates greater pain intensity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate	NCT01613144	Osteoporosis Poor Bone Quali...	OsseoScrew Spin...	18 Years -	Alphatec Spine, Inc.
OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate	NCT01613144	Osteoporosis Poor Bone Quali...	OsseoScrew Spin...	18 Years -	Alphatec Spine, Inc.

Spots Global Cancer Trial Database for poor bone quality