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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT04041583
Status
Recruiting

Conditions

  • Cervical Fusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 \[2\].

Study Details

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.

Key Dates

Start date
Sep 1, 2019
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
45 participants (estimated)

Arms

  • Arm: 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)

Primary Outcome Measure

Cervical Fusion [ Time Frame: 2-Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical CenterColumbusOhio43210
Aladdin A Alqaisi, MS
614-814-7007
Allie Garvin, BS
614-688-8304
Andrew Grossbach, MD (PRINCIPAL_INVESTIGATOR)

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