Biological 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/21916134/Actively Recruiting
Led by Ohio State University · Updated on 2025-12-30
45
Participants Needed
1
Research Sites
N/A
Total Duration
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
Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
A
Aladdin A Alqaisi, MPH
A
Allie Garvin, BS
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Ohio State University
Lead Sponsor
Medtronic
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Praveen V Mummaneni, Scott A Meyer, Jau-Ching Wu
https://pubmed.ncbi.nlm.nih.gov/21916134/Lee A Tan, Carter S Gerard, Paul A Anderson...
https://pubmed.ncbi.nlm.nih.gov/24328759/Mazda K Turel, Mena G Kerolus, Vincent C Traynelis
https://pubmed.ncbi.nlm.nih.gov/29403245/Lee A Tan, David C Straus, Vincent C Traynelis
https://pubmed.ncbi.nlm.nih.gov/25679233/Manish K Kasliwal, Jacquelyn A Corley, Vincent C Traynelis
https://pubmed.ncbi.nlm.nih.gov/26516824/Guy R Fogel, John S Toohey, Arvo Neidre...
https://pubmed.ncbi.nlm.nih.gov/17544854/Ohio State University
Lead Sponsor
Medtronic
Collaborating Sponsor