Effect of machined interfacet allograft spacers on cervical foraminal height and area.
Lee A Tan, Carter S Gerard, Paul A Anderson...
https://pubmed.ncbi.nlm.nih.gov/24328759Actively Recruiting
Age: 18Years +
All Genders
ID04041583
Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
Led by Ohio State University · Updated on 2025-12-30
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess fusion rates and cervical spine alignment following posterior cervical arthrodesis surgeries supplemented with cervical interfacet spacers (CIS). These procedures are done for conditions like degenerative cervical spondylosis, deformity, tumors, or trauma affecting the cervical spine. The study focuses on how CIS, a device placed under tension in the spine, may improve bone fusion and potentially reduce complications such as nerve root compression and C5 palsy. Participants will undergo posterior cervical fusion surgery involving three or more spinal segments in the neck and upper thoracic region, with CIS used to support the fusion. Data will be collected from medical records, including demographic details, surgical information, clinical status before surgery, and imaging results. Additionally, participants will have a non-standard CT scan two years after surgery to evaluate fusion and spinal alignment. Throughout the study, researchers will collect and review various data for up to two years after surgery, including X-rays, CT scans, and patient-reported outcomes on pain and function. Neurological events will also be monitored. The primary outcomes are the rate of cervical fusion and spinal alignment after two years. Secondary outcomes include pain scores, disability indexes, quality of life measures, and any neurological complications. This detailed follow-up helps understand the long-term effects of CIS in cervical spine surgery.
CONDITIONS
Brief Title
Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Symptomatic multi-level degenerative spondylosis needing posterior cervical arthrodesis between C2 and upper thoracic spine
- Surgery performed at The Ohio State University Wexner Medical Center Department of Neurological Surgery
You will not qualify if you...
- Traumatic injury
- Use of medications that may interfere with bone or soft tissue healing (e.g., high dose glucocorticoids, immunosuppressants, methotrexate) as determined by investigator
- Severe heart, respiratory, or kidney disease
- Recent (less than 3 years) or current spinal tumor or infection
- Participation in another investigational drug or device study that could affect results
- History of substance abuse that may interfere with assessments or follow-up
- Pregnant or planning pregnancy within 24 months
- Prisoner
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Hospital stay duration as per routine care
Participants undergo posterior cervical arthrodesis surgery supplemented with cervical interfacet spacers, followed by immediate post-operative care.
Hospital-based care during surgery and immediate recovery
Post-operative Follow-up
Duration - Up to 2 years
Participants are followed after surgery to assess cervical fusion, alignment, neurological status, and patient-reported outcomes.
Regular follow-up visits including radiographs and assessments over 2 years
Trial Site Locations
Total: 1 location
1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
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Research Team
A
Aladdin A Alqaisi, MPH
A
Allie Garvin, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Posterior Cervical Fusion Using Cervical Interfacet Spacers in Patients With Symptomatic Cervical Pseudarthrosis.
Manish K Kasliwal, Jacquelyn A Corley, Vincent C Traynelis
https://pubmed.ncbi.nlm.nih.gov/26516824Biological approaches to spinal instrumentation and fusion in spinal deformity surgery.
Praveen V Mummaneni, Scott A Meyer, Jau-Ching Wu
https://pubmed.ncbi.nlm.nih.gov/21916134Cervical interfacet spacers and maintenance of cervical lordosis.
Lee A Tan, David C Straus, Vincent C Traynelis
https://pubmed.ncbi.nlm.nih.gov/25679233Fusion assessment of posterior lumbar interbody fusion using radiolucent cages: X-ray films and helical computed tomography scans compared with surgical exploration of fusion.
Guy R Fogel, John S Toohey, Arvo Neidre...
https://pubmed.ncbi.nlm.nih.gov/17544854Machined cervical interfacet allograft spacers for the management of atlantoaxial instability.
Mazda K Turel, Mena G Kerolus, Vincent C Traynelis
https://pubmed.ncbi.nlm.nih.gov/29403245