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Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers

NCT04041583 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-12-30

No results posted yet for this study

Summary

This is a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS. Data will be collected from medical records for up to 730 days after surgery. Data to be collected will be demographic, preoperative clinical information, surgical details, and radiographic information. Patients will also undergo a non-standard of care CT scan 2 years after surgery.

Conditions

  • Cervical Fusion

Interventions

DEVICE

Cervical Interfacet Spacers

The use of Cervical Interfacet Spacers is a relatively novel technique shown to be useful for posterior fusion to address symptomatic pseudoarthrosis (fusion failure) after anterior cervical arthrodesis \[2\]. CIS have a relatively large osteoconductive surface area and are placed under tension in the interfacet space, which together favorably influence bony fusion \[2\].

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
2026-08-31
Completion
2026-08-31
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 NCT04041583 on ClinicalTrials.gov