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

NCT04214535 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2019-273
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Disc Herniation; Cervical Disc Degeneration; Degenerative Disc Disease

Keywords

Cervical Fusion; Cervical Disc Degeneration; Spinal Fusion; Tritanium® C Anterior Cervical Cage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Visual Analog Scale for Pain

  24 months postoperative

• Neck Disability Index for Pain and Function

  24 months postoperative

• Short Form Health Survey-36 for Quality of Life

  24 months postoperative

• Eating Assessment Tool - 10 for Dysphagia

  24 months postoperative

• Neurological Deficit as defined by Cervical Spine Examination

  24 months postoperative

Study Arms (1)

Tritanium C Anterior Cervical Cage

EXPERIMENTAL

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

Interventions

Tritanium C Anterior Cervical Cage DEVICE

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

Tritanium C Anterior Cervical Cage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Corewell Health East: lead
• Stryker Spine: collaborator

Study Sites (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (13)

• 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.

  PMID: 25907826 BACKGROUND

• 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.

  PMID: 28264242 BACKGROUND

• 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.

  PMID: 22089645 BACKGROUND

• Epstein NE. Iliac crest autograft versus alternative constructs for anterior cervical spine surgery: Pros, cons, and costs. Surg Neurol Int. 2012;3(Suppl 3):S143-56. doi: 10.4103/2152-7806.98575. Epub 2012 Jul 17.

  PMID: 22905321 BACKGROUND

• Kolstad F, Nygaard OP, Andresen H, Leivseth G. Anterior cervical arthrodesis using a "stand alone" cylindrical titanium cage: prospective analysis of radiographic parameters. Spine (Phila Pa 1976). 2010 Jul 15;35(16):1545-50. doi: 10.1097/BRS.0b013e3181d259c1.

  PMID: 20581756 BACKGROUND

• van Jonbergen HP, Spruit M, Anderson PG, Pavlov PW. Anterior cervical interbody fusion with a titanium box cage: early radiological assessment of fusion and subsidence. Spine J. 2005 Nov-Dec;5(6):645-9; discussion 649. doi: 10.1016/j.spinee.2005.07.007.

  PMID: 16291105 BACKGROUND

• Schmieder K, Wolzik-Grossmann M, Pechlivanis I, Engelhardt M, Scholz M, Harders A. Subsidence of the wing titanium cage after anterior cervical interbody fusion: 2-year follow-up study. J Neurosurg Spine. 2006 Jun;4(6):447-53. doi: 10.3171/spi.2006.4.6.447.

  PMID: 16776355 BACKGROUND

• Singh P, Kumar A, Shekhawat V. Comparative Analysis of Interbody Cages Versus Tricortical Graft with Anterior Plate Fixation for Anterior Cervical Discectomy and Fusion in Degenerative Cervical Disc Disease. J Clin Diagn Res. 2016 Mar;10(3):RC05-8. doi: 10.7860/JCDR/2016/16520.7340. Epub 2016 Mar 1.

  PMID: 27134955 BACKGROUND

• Wu WJ, Jiang LS, Liang Y, Dai LY. Cage subsidence does not, but cervical lordosis improvement does affect the long-term results of anterior cervical fusion with stand-alone cage for degenerative cervical disc disease: a retrospective study. Eur Spine J. 2012 Jul;21(7):1374-82. doi: 10.1007/s00586-011-2131-9. Epub 2011 Dec 29.

  PMID: 22205113 BACKGROUND

• Schimmel JJ, Poeschmann MS, Horsting PP, Schonfeld DH, van Limbeek J, Pavlov PW. PEEK Cages in Lumbar Fusion: Mid-term Clinical Outcome and Radiologic Fusion. Clin Spine Surg. 2016 Jun;29(5):E252-8. doi: 10.1097/BSD.0b013e31826eaf74.

  PMID: 27196005 BACKGROUND

• Liu H, Ploumis A, Li C, Yi X, Li H. Polyetheretherketone cages alone with allograft for three-level anterior cervical fusion. ISRN Neurol. 2012;2012:452703. doi: 10.5402/2012/452703. Epub 2012 Feb 1.

  PMID: 22462020 BACKGROUND

• Maharaj MM, Phan K, Mobbs RJ. Anterior cervical discectomy and fusion (ACDF) autograft versus graft substitutes: what do patients prefer?-A clinical study. J Spine Surg. 2016 Jun;2(2):105-10. doi: 10.21037/jss.2016.05.01.

  PMID: 27683706 BACKGROUND

• Cabraja M, Oezdemir S, Koeppen D, Kroppenstedt S. Anterior cervical discectomy and fusion: comparison of titanium and polyetheretherketone cages. BMC Musculoskelet Disord. 2012 Sep 14;13:172. doi: 10.1186/1471-2474-13-172.

  PMID: 22978810 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Klippel-Feil Syndrome

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Dysostoses; Bone Diseases, Developmental; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jad G Khalil, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 2, 2020
• Study Start: May 5, 2021
• Primary Completion: March 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)