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

NCT04041583 | Recruiting FDA Device

• 1 other identifier: 2019H0015
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Cervical Fusion

  Cervical Fusion Measured on Post-Operative Radiographs and CT scans

  2-Years

• Cervical Sagittal Alignment Parameters

  Cervical Sagittal Alignment Parameters measured on post-operative radiographs

  2-Years

Secondary Outcomes (4)

• NRS

  2-Years

• NDI

  2-Years

• SF-36 RAND

  2-Years

• Neurological Adverse Events

  2-Years

Study Arms (1)

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)

Device: Cervical Interfacet Spacers

Interventions

Cervical Interfacet Spacers DEVICE

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 \[2\].

Also known as: (CIS; CORNERSTONE Facet MicroGrafts, Medtronic, Minneapolis, MN)

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Medtronic: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (6)

• Tan LA, Gerard CS, Anderson PA, Traynelis VC. Effect of machined interfacet allograft spacers on cervical foraminal height and area. J Neurosurg Spine. 2014 Feb;20(2):178-82. doi: 10.3171/2013.11.SPINE131. Epub 2013 Dec 13.

  PMID: 24328759 RESULT

• Kasliwal MK, Corley JA, Traynelis VC. Posterior Cervical Fusion Using Cervical Interfacet Spacers in Patients With Symptomatic Cervical Pseudarthrosis. Neurosurgery. 2016 May;78(5):661-8. doi: 10.1227/NEU.0000000000001087.

  PMID: 26516824 RESULT

• Mummaneni PV, Meyer SA, Wu JC. Biological approaches to spinal instrumentation and fusion in spinal deformity surgery. Clin Neurosurg. 2011;58:110-6. doi: 10.1227/neu.0b013e3182270009. No abstract available.

  PMID: 21916134 RESULT

• Tan LA, Straus DC, Traynelis VC. Cervical interfacet spacers and maintenance of cervical lordosis. J Neurosurg Spine. 2015 May;22(5):466-9. doi: 10.3171/2014.10.SPINE14192. Epub 2015 Feb 13.

  PMID: 25679233 RESULT

• Fogel GR, Toohey JS, Neidre A, Brantigan JW. Fusion assessment of posterior lumbar interbody fusion using radiolucent cages: X-ray films and helical computed tomography scans compared with surgical exploration of fusion. Spine J. 2008 Jul-Aug;8(4):570-7. doi: 10.1016/j.spinee.2007.03.013. Epub 2007 May 29.

  PMID: 17544854 RESULT

• Turel MK, Kerolus MG, Traynelis VC. Machined cervical interfacet allograft spacers for the management of atlantoaxial instability. J Craniovertebr Junction Spine. 2017 Oct-Dec;8(4):332-337. doi: 10.4103/jcvjs.JCVJS_87_17.

  PMID: 29403245 RESULT

MeSH Terms

Conditions

Klippel-Feil Syndrome

Condition Hierarchy (Ancestors)

Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andrew Grossbach, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aladdin A Alqaisi, MPH

CONTACT

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

Allie Garvin, BS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Clinical Professor

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 1, 2019
• Study Start: September 1, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)