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OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

NCT01613144 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2022-02-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

OsseoScrew Spinal Fixation System

Surgical intervention

Sponsors & Collaborators

  • Alphatec Spine, Inc.

    lead INDUSTRY

Principal Investigators

  • Bita Ghadimi · Alphatec Spine, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2017-02-12
Completion
2017-11-08
FDA Device
Yes

Countries

  • Belgium
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01613144 on ClinicalTrials.gov