Clinical trial NCT04214535: Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Disc Herniation
Cervical Disc Degeneration
Degenerative Disc Disease
Keywords: Cervical Fusion
Cervical Disc Degeneration
Spinal Fusion
Tritanium® C Anterior Cervical Cage
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Stryker Spine
First posted: 2020-01-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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 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

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Primary outcomes:
measure: Incidence of successful cervical fusion measured radiographically
timeFrame: 12 months postoperative
Secondary outcomes:
measure: Visual Analog Scale for Pain
timeFrame: 24 months postoperative
measure: Neck Disability Index for Pain and Function
timeFrame: 24 months postoperative
measure: Short Form Health Survey-36 for Quality of Life
timeFrame: 24 months postoperative
measure: Eating Assessment Tool - 10 for Dysphagia
timeFrame: 24 months postoperative
measure: Neurological Deficit as defined by Cervical Spine Examination
timeFrame: 24 months postoperative
measure: Count of participants with development of pseudoarthrosis by month 12
timeFrame: 24 months postoperative
measure: Count of participants with revision surgery by month 12
timeFrame: 24 months postoperative
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont University Hospital
state: Michigan
Study officials:
affiliation: Beaumont Health
name: Jad G Khalil, MD
role: PRINCIPAL_INVESTIGATOR
References:
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