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

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.

Conditions

Cervical Disc Herniation, Cervical Disc Degeneration, Degenerative Disc Disease

Study Overview

Study Details

Study overview

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.

Anterior Cervical Disectomy and Fusion Using the Tritanium® C Anterior Cervical Cage for One or Two-Levels: a Clinical and Radiographic Analysis Pilot Study

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

Condition
Cervical Disc Herniation
Intervention / Treatment

-

Contacts and Locations

Royal Oak

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 with increasing signs and symptoms of cervical myelopathy or radiculopathy that may require immediate intervention -
  • 1. Any prior history of cervical fusion 2. Requires cervical fusion of more than two levels or not contiguous levels 3. Acute cervical spine trauma requiring immediate intervention 4. BMI \> 40 5. Active systemic bacterial or fungal infection or infection at the operative site 6. History of vertebral fracture or osteoporotic fracture 7. Current treatment with chemotherapy, radiation, immunosuppression or chronic steroid therapy 8. History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal surgery 9. Psychological or physical condition in the opinion of the investigator that would interfere with completing study participation including completion of patient reported outcomes 10. History of neurological condition in the opinion of the investigator that may affect cervical spine function and pain assessments 11. Subjects with a history of cancer must be disease free for at least 3 years; with the exception of squamous cell skin carcinoma 12. Pregnant, or plans on becoming pregnant 13. History of allergy to titanium

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

William Beaumont Hospitals,

Jad G Khalil, MD, PRINCIPAL_INVESTIGATOR, Beaumont Health

Study Record Dates

2024-12-30