Anterior Cervical Disectomy and Fusion Using the Tritanium® C Anterior Cervical Cage for One or Two-Levels

Last updated: February 13, 2025
Sponsor: William Beaumont Hospitals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Radiculopathy

Treatment

Tritanium C Anterior Cervical Cage

Clinical Study ID

NCT04214535
2019-273
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients undergoing a one or two (contiguous) level primary ACDF between C2-T1

  2. Able to provide consent

  3. ≥ 18 years of age and skeletally mature

  4. Diagnosis of symptomatic degenerative disc disease, including; myelopathy,radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus,spondylosis, osteophyte complexes, and foraminal stenosis

  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. Baseline Neck Disability score ≥ 20

  7. Had at least 6-weeks of conservative non-operative treatment and/or presents withincreasing signs and symptoms of cervical myelopathy or radiculopathy that mayrequire immediate intervention -

Exclusion

Exclusion Criteria:

  1. Any prior history of cervical fusion 2. Requires cervical fusion of more than twolevels or not contiguous levels 3. Acute cervical spine trauma requiring immediateintervention 4. BMI > 40 5. Active systemic bacterial or fungal infection orinfection at the operative site 6. History of vertebral fracture or osteoporoticfracture 7. Current treatment with chemotherapy, radiation, immunosuppression orchronic steroid therapy 8. History of osteoporosis, osteopenia, or osteomalacia thatwould contraindicate spinal surgery 9. Psychological or physical condition in theopinion of the investigator that would interfere with completing study participationincluding completion of patient reported outcomes 10. History of neurologicalcondition in the opinion of the investigator that may affect cervical spine functionand pain assessments 11. Subjects with a history of cancer must be disease free forat least 3 years; with the exception of squamous cell skin carcinoma 12. Pregnant,or plans on becoming pregnant 13. History of allergy to titanium

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Tritanium C Anterior Cervical Cage
Phase:
Study Start date:
May 05, 2021
Estimated Completion Date:
December 30, 2026

Study Description

Degenerative disc disease of the cervical (neck) spine occurs when the discs between the vertebral bony bodies start to deteriorate or break down due to wear and tear over time. It is diagnosed as such once it is symptomatic and causes neck pain and radiculopathy (arm pain, weakness, and/or numbness). In order to correct the damaged disc and resolve radicular symptoms, anterior cervical discectomy and fusion surgery is commonly performed.

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 C2-T1 and diagnosed with degenerative disc disease will be screened for the study. Subjects will be followed up postoperatively per standard of care at 6-weeks, 3-monts, 6-months, 12-months and at 24-months at the private practice or hospital clinic. The primary end-point is Successful cervical spinal fusion as measured by dynamic (flexion and extension) x-rays and CT scan (using metal subtraction) at 12 months and as evidenced by the following three criteria: bony bridging, no presence of radiolucency, and no development of pseudoarthrosis at the treated cervical level.

Connect with a study center

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

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