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Observational Study of Cervical Interfacet Spacers for Cervical Fusion

This study is looking at how well Cervical Interfacet Spacers (CIS) work when added to posterior cervical fusion surgery. CIS are small devices that help with fusion, especially when a previous fusion has failed. Researchers want to see if using CIS improves fusion rates and helps keep your neck alignment correct. You could join if you are at least 18 years old, need posterior cervical fusion for multi-level degenerative spondylosis (wear and tear in your neck), and are having surgery at The Ohio State University Wexner Medical Center. The study will track your progress for two years after surgery to see how well your fusion heals and if your neck alignment improves. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 45 participants. It will collect information from medical records and a special CT scan.
What's involved
You will undergo a non-standard CT scan two years after your surgery. Other data will be collected from your medical records.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 730 days (approximately two years) after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04041583

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

Recruiting
Not specifiedAges 18+Observational
Ohio State University
~45 participants
Updated 2025-12-30 on ClinicalTrials.gov
What's tested:Cervical Interfacet Spacers

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cervical Fusion
Measured over 2-Years
+1 more outcome measured

Conditions

Cervical Fusion

Explore related trials

Degenerative spondylolisthesis

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Andrew Grossbach, MD · PRINCIPAL_INVESTIGATOR · Ohio State University

Who to contact

Aladdin A Alqaisi, MPH
[email protected]
614-814-7007
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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)

Exclusion

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

What this trial measures

  • Cervical Fusion2-Years

    Cervical Fusion Measured on Post-Operative Radiographs and CT scans

  • Cervical Sagittal Alignment Parameters2-Years

    Cervical Sagittal Alignment Parameters measured on post-operative radiographs