Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cervical Disc Degeneration
- Cervical Disc Herniation
- Degenerative Disc Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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 deviceMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04214535
- Collaborators
- Stryker Spine
- Investigators
- Principal Investigator: Jad G Khalil, MD Beaumont Health