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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04214535
Recruitment Status : Not yet recruiting
First Posted : January 2, 2020
Last Update Posted : April 7, 2020
Sponsor:
Collaborator:
Stryker Spine
Information provided by (Responsible Party):
Jad Khalil MD, William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Cervical Disc Herniation Cervical Disc Degeneration Degenerative Disc Disease Device: Tritanium C Anterior Cervical Cage Not Applicable

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, and 12-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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tritanium C Anterior Cervical Cage
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
50 subjects undergoing anterior cervical discectomy and fusion surgery using the Tritanium C Anterior Cage for one or two-levels




Primary Outcome Measures :
  1. Incidence of successful cervical fusion measured radiographically [ Time Frame: 12 months postoperative ]
    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).


Secondary Outcome Measures :
  1. Visual Analog Scale for Pain [ Time Frame: 12 months postoperative ]
    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 12-months

  2. Neck Disability Index for Pain and Function [ Time Frame: 12 months postoperative ]
    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 12-months.

  3. Short Form Health Survey-36 for Quality of Life [ Time Frame: 12 months postoperative ]
    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 12-months

  4. Eating Assessment Tool - 10 for Dysphagia [ Time Frame: 12 months postoperative ]
    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 12-months.

  5. Neurological Deficit as defined by Cervical Spine Examination [ Time Frame: 12 months postoperative ]
    Count of participants with new or worsening neurological cervical spine deficit as evaluated by cervical spine examination (motor and sensory) from baseline to 12-months

  6. Count of participants with development of pseudoarthrosis by month 12 [ Time Frame: 12 months postoperative ]
    Count of participants with development of pseudoarthrosis by month 12 as a result of device subsidence, migration, loosening or overall device failure.

  7. Count of participants with revision surgery by month 12 [ Time Frame: 12 months postoperative ]
    Count of participants with revision surgery by month 12 as a result of device subsidence, migration, loosening, or overall device failure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04214535


Contacts
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Contact: Lisa Motowski, RN 248-551-6679 lisa.motowski@beaumont.org

Locations
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United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Stryker Spine
Investigators
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Principal Investigator: Jad G Khalil, MD Beaumont Health
Publications:

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Responsible Party: Jad Khalil MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT04214535    
Other Study ID Numbers: 2019-273
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jad Khalil MD, William Beaumont Hospitals:
Cervical Fusion
Cervical Disc Degeneration
Spinal Fusion
Tritanium® C Anterior Cervical Cage
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases