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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

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:

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

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

NCT ID

NCT04214535

First Posted

December 27, 2019

Last Updated

July 11, 2023

Sponsor

William Beaumont Hospitals

Collaborators

Stryker Spine

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

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

Time Frame

12 months postoperative

Secondary Outcome Measure Information:

Title

Visual Analog Scale for Pain

Description

Time Frame

24 months postoperative

Title

Neck Disability Index for Pain and Function

Description

Time Frame

24 months postoperative

Title

Short Form Health Survey-36 for Quality of Life

Description

Time Frame

24 months postoperative

Title

Eating Assessment Tool - 10 for Dysphagia

Description

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

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

grace.sanagustin@beaumont.org

First Name & Middle Initial & Last Name or Official Title & Degree

Pamela Sloan, RN

Phone

248 551 6059

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

grace.sanagustin@beaumont.org

First Name & Middle Initial & Last Name & Degree

Pamela Sloan, RN

Phone

248 551 6059

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

Citations:

PubMed Identifier

25907826

Citation

Chong E, Pelletier MH, Mobbs RJ, Walsh WR. The design evolution of interbody cages in anterior cervical discectomy and fusion: a systematic review. BMC Musculoskelet Disord. 2015 Apr 25;16:99. doi: 10.1186/s12891-015-0546-x.

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Citation

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.

Results Reference

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PubMed Identifier

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Citation

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Citation

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PubMed Identifier

20581756

Citation

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Citation

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Citation

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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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