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

ConditionCervical Fusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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)

Disqualifiers

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

Trial 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)

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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 \[2\].

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Arm 11 intervention

Trial outcomes

Primary outcomes

1

Cervical Fusion

Cervical Fusion Measured on Post-Operative Radiographs and CT scans

Time frame
2-Years
2

Cervical Sagittal Alignment Parameters

Cervical Sagittal Alignment Parameters measured on post-operative radiographs

Time frame
2-Years

Secondary outcomes

1

NRS

Numerical Rating Score for Pain from 0-10 where lower values represent a better outcome

Time frame
2-Years
2

NDI

Neck Disability Index from 0-100% where lower values represent a better outcome

Time frame
2-Years
3

SF-36 RAND

Quality of Life Measures from 0-100 where higher values represent a better outcome

Time frame
2-Years
4

Neurological Adverse Events

Adverse Events

Time frame
2-Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov
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