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

Primary Purpose

Cervical Disc Herniation, Cervical Disc Degeneration, Degenerative Disc Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tritanium C Anterior Cervical Cage
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Disc Herniation focused on measuring Cervical Fusion, Cervical Disc Degeneration, Spinal Fusion, Tritanium® C Anterior Cervical Cage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • William Beaumont HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tritanium C Anterior Cervical Cage

Arm Description

50 subjects undergoing anterior cervical discectomy and fusion surgery using the Tritanium C Cervical Cage at one or two-levels

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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.
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
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.
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
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.
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.

Full Information

First Posted
December 27, 2019
Last Updated
July 11, 2023
Sponsor
William Beaumont Hospitals
Collaborators
Stryker Spine
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1. Study Identification

Unique Protocol Identification Number
NCT04214535
Brief Title
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Acronym
STRYKER
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
Collaborators
Stryker Spine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Herniation, Cervical Disc Degeneration, Degenerative Disc Disease
Keywords
Cervical Fusion, Cervical Disc Degeneration, Spinal Fusion, Tritanium® C Anterior Cervical Cage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tritanium C Anterior Cervical Cage
Arm Type
Experimental
Arm Description
50 subjects undergoing anterior cervical discectomy and fusion surgery using the Tritanium C Cervical Cage at one or two-levels
Intervention Type
Device
Intervention Name(s)
Tritanium C Anterior Cervical Cage
Intervention Description
50 subjects undergoing anterior cervical discectomy and fusion surgery using the Tritanium C Anterior Cage for one or two-levels
Primary Outcome Measure Information:
Title
Incidence of successful cervical fusion measured radiographically
Description
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).
Time Frame
12 months postoperative
Secondary Outcome Measure Information:
Title
Visual Analog Scale for Pain
Description
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
Time Frame
24 months postoperative
Title
Neck Disability Index for Pain and Function
Description
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.
Time Frame
24 months postoperative
Title
Short Form Health Survey-36 for Quality of Life
Description
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
Time Frame
24 months postoperative
Title
Eating Assessment Tool - 10 for Dysphagia
Description
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.
Time Frame
24 months postoperative
Title
Neurological Deficit as defined by Cervical Spine Examination
Description
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
Time Frame
24 months postoperative
Title
Count of participants with development of pseudoarthrosis by month 12
Description
Count of participants with development of pseudoarthrosis by month 24 as a result of device subsidence, migration, loosening or overall device failure.
Time Frame
24 months postoperative
Title
Count of participants with revision surgery by month 12
Description
Count of participants with revision surgery by month 24 as a result of device subsidence, migration, loosening, or overall device failure.
Time Frame
24 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace San Agustin, RN
Phone
248-551-6679
Email
grace.sanagustin@beaumont.org
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Sloan, RN
Phone
248 551 6059
Email
pamela.sloan@beaumont.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jad G Khalil, MD
Organizational Affiliation
Beaumont Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace San Agustin, RN
Phone
248-551-6679
Email
grace.sanagustin@beaumont.org
First Name & Middle Initial & Last Name & Degree
Pamela Sloan, RN
Phone
248 551 6059
Email
Pamela.Sloan@beaumont.org
First Name & Middle Initial & Last Name & Degree
Jeffrey S Fischgrund, MD
First Name & Middle Initial & Last Name & Degree
Daniel K Park, MD
First Name & Middle Initial & Last Name & Degree
Mark Jacobson, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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25907826
Citation
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Kim SH, Lee JK, Jang JW, Park HW, Hur H. Polyetheretherketone Cage with Demineralized Bone Matrix Can Replace Iliac Crest Autografts for Anterior Cervical Discectomy and Fusion in Subaxial Cervical Spine Injuries. J Korean Neurosurg Soc. 2017 Mar;60(2):211-219. doi: 10.3340/jkns.2015.0203.014. Epub 2017 Mar 1.
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Faldini C, Chehrassan M, Miscione MT, Acri F, d'Amato M, Pungetti C, Luciani D, Giannini S. Single-level anterior cervical discectomy and interbody fusion using PEEK anatomical cervical cage and allograft bone. J Orthop Traumatol. 2011 Dec;12(4):201-5. doi: 10.1007/s10195-011-0169-4. Epub 2011 Nov 17.
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Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels

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