Recruiting

Cervical Arthrodesis with CIS

Sponsor:

Ohio State University

Code:

NCT04041583

Conditions

Cervical Fusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cervical Interfacet Spacers

Study Details

Brief 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

Study ID

NCT04041583

Start date

Sep 1, 2019

Status verified date

Dec, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Arm 1

Patients undergoing posterior cervical arthrodesis procedures for spondylosis supplemented with CIS involving three or more segmental levels in the subaxial cervicothoracic spine (between C2-upper thoracic)

Interventions

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 \[2\].

Primary outcome measure

  • Cervical Fusion [ Time Frame: 2-Years ]
  • Cervical Sagittal Alignment Parameters [ Time Frame: 2-Years ]

Central Contacts and Locations

Central contacts

Aladdin A Alqaisi, MPH

614-814-7007Aladdin.Alqaisi@osumc.edu

Allie Garvin, BS

614-688-8304allison.garvin@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Aladdin A Alqaisi, MS

614-814-7007Aladdin.Alqaisi@osumc.edu

Allie Garvin, BS

614-688-8304allison.garvin@osumc.edu

Principal Investigator:

Andrew Grossbach, MD

More Information

Sponsor

Ohio State University

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-12-30.