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Clinical and Radiological Outcomes of Posterior Cervical Fusion with Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System

NCT04056520 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2025-03-21

No results posted yet for this study

Summary

This study is being done to prospectively collect data on subjects having posterior cervical fusion surgery using the Medtronic Infinity system. Researchers plan to collect information from patients having this type of surgery in order to learn more about patient how patients do after the surgery, including the rate of bone healing following surgery.

The goal is for 250 patients to take part in the study or for 500 screws to be used, whichever comes first. Each patient will need a varying amount of screws to be used during their surgery. Because we are measuring the accuracy of each individual screw and the surgeon will likely use multiple screws during each surgery, it is likely that the study will reach its goal of 500 screws before 250 patients are enrolled in the study.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

Medtronic Infinity Occipitocervical-Upper Thoracic System using the O-arm Imaging System and StealthStation Navigation system

The INFINITY™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: * Traumatic spinal fractures and/or traumatic dislocations. * Instability or deformity. * Failed previous fusions (e.g. pseudarthrosis). * Tumors involving the cervical spine. * Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/ or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Andrew Grossbach, MD · Ohio State University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-11-30
Completion
2024-12-13
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04056520 on ClinicalTrials.gov