RECRUITING

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

Description

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
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Related Conditions:

Cervical Fusion

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cervical Fusion
Intervention / Treatment

-

Contacts and Locations

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ≥ 18 years old
  • * Symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis in the subaxial cervicothoracic spine (between C2-upper thoracic).
  • * Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
  • * Traumatic injury
  • * Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator
  • * Severe co-morbidities (e.g., heart, respiratory, or renal disease)
  • * Recent (\<3 yrs) or co-incident spinal tumor or infection
  • * Concurrent involvement in another investigational drug or device study that could confound study data
  • * History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
  • * Subjects who are pregnant or plan to become pregnant in the next 24 months
  • * Prisoner

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Andrew Grossbach, MD, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

Study Record Dates

2025-08