Evaluation of Safety and Effectiveness of Primary Hybrid Construct of Mobi-C and ACDF in the Treatment of Two-level Symptomatic Degenerative Disc Disease in the Cervical Spine.
NCT Number: NCT06485206
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Degenerative Disc Disease
Interventions: DEVICE: One level Mobi-C and one level fusion
Sponsor: ZimVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 97
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-02

Summary:
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.

Primary Outcome Measures: Composite 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, 24 months
Secondary Outcome Measures: 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., 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., 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., 24 months|Muscle Strength, Clinical outcome, 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., 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., 24 months|Adjacent Segment Degeneration, Radiological assessment using Kellgren-Lawrence classification system to measure degeneration occurring in levels around the operated spine., 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., 24 months|Subsidence, Radiographic outcome, 24 months|Segmental Range of Motion, Radiographic outcome, 24 months|C2-C7 range of motion, radiographic outcome, 24 months|radiolucency measure, radiographic outcome, 24 months|Patient Satisfaction Questionnaire, Self-reported questionnaire to assess patient satisfaction of the surgical treatment outcomes, 24 months|quality of life survey (SF-12), Patient reported outcome measure, 24 months|Dysphagia, Dysphagia will be assessed using Functional Outcome Swallowing Scale (FOSS), 24 months|Gait Analysis, Gait will be assessed by physician during neurological examination, 24 months
Other Outcome Measures: Duration of Hospitalization, Clinical outcome, 6 weeks|Blood Loss, clinical outcome, 6 weeks|Operative Time, clinical outcome, intraoperative|Return to Work, Clinical outcome will be measured by patient self-report of time since surgery before returning to work measured in days., 6 weeks|Headache Outcome (HIT-6), patient reported outcome, 24 months