ACTIVE_NOT_RECRUITING

Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels

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Conditions

Cervical Disc HerniationCervical Disc DegenerationDegenerative Disc DiseaseCervical FusionSpinal FusionTritanium® C Anterior Cervical Cage

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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, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) between the levels of Cervical Spine 2 to Thoracic 1 (C2-T1) and diagnosed with degenerative disc disease will be screened for the study.

Official Title

Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels: A Clinical And Radiographic Analysis Pilot Study

Quick Facts

Study Start:2021-05-05
Study Completion:2027-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04214535

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. 1. Patients undergoing a one or two (contiguous) level primary ACDF between C2-T1
  2. 2. Able to provide consent
  3. 3. ≥ 18 years of age and skeletally mature
  4. 4. Diagnosis of symptomatic degenerative disc disease, including; myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, spondylosis, osteophyte complexes, and foraminal stenosis
  5. 5. Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4 (0-10cm scale) for neck or arm pain
  6. 6. Baseline Neck Disability score ≥ 20
  7. 7. Had at least 6-weeks of conservative non-operative treatment and/or presents with increasing signs and symptoms of cervical myelopathy or radiculopathy that may require immediate intervention -
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Jad G Khalil, MD
PRINCIPAL_INVESTIGATOR
Beaumont Health

Study Locations (Sites)

Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
United States

Collaborators and Investigators

Sponsor: William Beaumont Hospitals

  • Jad G Khalil, MD, PRINCIPAL_INVESTIGATOR, Beaumont Health

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 Date2021-05-05
Study Completion Date2027-03-30

Study Record Updates

Study Start Date2021-05-05
Study Completion Date2027-03-30

Terms related to this study

Keywords Provided by Researchers

  • Cervical Fusion
  • Cervical Disc Degeneration
  • Spinal Fusion
  • Tritanium® C Anterior Cervical Cage

Additional Relevant MeSH Terms

  • Cervical Disc Herniation
  • Cervical Disc Degeneration
  • Degenerative Disc Disease