RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-09-01
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04041583

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years old
  2. * Symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis in the subaxial cervicothoracic spine (between C2-upper thoracic).
  3. * Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
  1. * Traumatic injury
  2. * 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
  3. * Severe co-morbidities (e.g., heart, respiratory, or renal disease)
  4. * Recent (\<3 yrs) or co-incident spinal tumor or infection
  5. * Concurrent involvement in another investigational drug or device study that could confound study data
  6. * 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
  7. * Subjects who are pregnant or plan to become pregnant in the next 24 months
  8. * Prisoner

Contacts and Locations

Study Contact

Shukri A Ahmed, MPH
CONTACT
614-814-7007
shukri.ahmed@osumc.edu
Allie Garvin, BS
CONTACT
614-688-8304
allison.garvin@osumc.edu

Principal Investigator

Andrew Grossbach, MD
PRINCIPAL_INVESTIGATOR
The Ohio State University Wexner Medical Center

Study Locations (Sites)

The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Andrew Grossbach, MD, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-01
Study Completion Date2025-08

Study Record Updates

Study Start Date2019-09-01
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Cervical Fusion