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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cervical Disc Herniation, Cervical Disc Degeneration, Degenerative Disc Disease

Intervention / Treatment
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* Device: Tritanium C Anterior Cervical Cage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a one or two (contiguous) level primary ACDF between C2-T1 Able to provide consent ≥ 18 years of age and skeletally mature Diagnosis of symptomatic degenerative disc disease, including; myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, spondylosis, osteophyte complexes, and foraminal stenosis Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4 (0-10cm scale) for neck or arm pain Baseline Neck Disability score ≥ 20 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 - Exclusion Criteria: 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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tritanium C Anterior Cervical Cage<br>50 subjects undergoing anterior cervical discectomy and fusion surgery using the Tritanium C Cervical Cage at one or two-levels | Device: Tritanium C Anterior Cervical Cage<br>* 50 subjects undergoing anterior cervical discectomy and fusion surgery using the Tritanium C Anterior Cage for one or two-levels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of successful cervical fusion measured radiographically | Count of participants with successful cervical fusion as measured by CT scan of the cervical spine and flexion and extension view x-rays at 12-months postoperative as evidenced by the following three criteria: bony bridging, no presence of radiolucency, and no development of pseudoarthrosis at the treated cervical level(s). | 12 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for Pain | Equal to or greater than 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 24-months | 24 months postoperative | 
| Neck Disability Index for Pain and Function | Equal to or greater than a 15-point decrease in patient reported outcomes as measured by Neck Disability Index (0-100 point scale, 0 = least amount of disability, 100 = most severe disability) from baseline to 24-months. | 24 months postoperative | 
| Short Form Health Survey-36 for Quality of Life | Equal to or greater than a 15-point improvement in patient reported outcomes as measured by SF-36 (0-100 point scale, 0=low favorable health state and 100 = most favorable health state) from baseline to 24-months | 24 months postoperative | 
| Eating Assessment Tool - 10 for Dysphagia | Scores less than 3 or equal to baseline (scores 3 or higher may indicate problems with swallowing efficiently and safely) in patient reported outcomes as measured by Eating Assessment tool - 10 from baseline to 24-months. | 24 months postoperative | 
| Neurological Deficit as defined by Cervical Spine Examination | Count of participants with new or worsening neurological cervical spine deficit as evaluated by cervical spine examination (motor and sensory) from baseline to 24-months | 24 months postoperative | 
| Count of participants with development of pseudoarthrosis by month 12 | Count of participants with development of pseudoarthrosis by month 24 as a result of device subsidence, migration, loosening or overall device failure. | 24 months postoperative | 
| Count of participants with revision surgery by month 12 | Count of participants with revision surgery by month 24 as a result of device subsidence, migration, loosening, or overall device failure. | 24 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Fusion, Cervical Disc Degeneration, Spinal Fusion, Tritanium® C Anterior Cervical Cage