The study is a prospective, multi-center cohort study of patients with two-level DDD implanted with CDA adjacent to ACDF (hybrid construct). The overall success of the hybrid procedure will be compared to 2-level ACDF historical controls from the Mobi-C IDE trial. 97 patients will receive the hybrid surgery and will be followed for a minimum of 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Cervical Disc Arthroplasty: • Mobi-C Fusion devices: * One-level cervical plates o MaxAn Cervical plate system * Interbody spacers * TrellOss-C - 3D printed Ti interbody * Vista-S - PEEK interbody * Standalone Fixation * Ti-Coated ROI-C - PEEK cage w/ Ti coating * TrellOss-C SA - 3D printed Ti * Bone Graft * Local Autograft * PrimaGen Advanced Allograft
University of California-Davis
Sacramento, California, United States
RECRUITINGMichigan Orthopaedic Surgeons
Southfield, Michigan, United States
RECRUITINGComposite Success
Statistical analysis of the combination of four components of success: improvement in Neck Disability Scale scores, no device failures, no major complications resulting in reoperations, no major AEs
Time frame: 24 months
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain.
Time frame: 24 months
Visual Analogue Scale- Neck Pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain in the neck.
Time frame: 24 months
Visual Analogue Scale- Arm Pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain in the arms.
Time frame: 24 months
Muscle Strength
Clinical outcome
Time frame: 24 months
Sensory Deficit
An assessment made by the surgeon with a neurological examination to determine if there is any change in sensation compared to the assessment before surgery.
Time frame: 24 months
Neurological Deficit
An assessment made by the surgeon with a neurological examination to determine if there is any change in neurological function compared to the assessment before surgery.
Time frame: 24 months
Adjacent Segment Degeneration
Radiological assessment using Kellgren-Lawrence classification system to measure degeneration occurring in levels around the operated spine.
Time frame: 24 months
Heterotopic Ossification
Radiological assessment using McAfee to measure bony growth on areas of motion in the Mobi-C level of the operated spine.
Time frame: 24 months
Subsidence
Radiographic outcome
Time frame: 24 months
Segmental Range of Motion
Radiographic outcome
Time frame: 24 months
C2-C7 range of motion
radiographic outcome
Time frame: 24 months
radiolucency measure
radiographic outcome
Time frame: 24 months
Patient Satisfaction Questionnaire
Self-reported questionnaire to assess patient satisfaction of the surgical treatment outcomes
Time frame: 24 months
quality of life survey (SF-12)
Patient reported outcome measure
Time frame: 24 months
Dysphagia
Dysphagia will be assessed using Functional Outcome Swallowing Scale (FOSS)
Time frame: 24 months
Gait Analysis
Gait will be assessed by physician during neurological examination
Time frame: 24 months
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