A Clinical Investigation Evaluating 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.
Highridge Medical
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.
Eligibility
- Age range
- 22–69 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 1\. Age 22 - 69 years. 2. Have symptoms of cervical degenerative disc disease (DDD) at two levels from C3 to T1 defined as intractable radiculopathy (arm pain and /or a neurological deficit) with or without neck pain or myelopathy due to a two-level abnormality localized to the level of the disc space. 3\. Radiographic evidence of at least one of the following: a. Spondylosis (defined by the presence of osteophytes or dark disc) on CT or MRI; or b. Disc height decreased by ≥1 mm when compared to adjacent levels on radiographic film, CT, or MRI; or c. Disc herniatio…
Interventions
- DeviceOne level Mobi-C and one level fusion
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
Locations (2)
- University of California-DavisSacramento, California
- Michigan Orthopaedic SurgeonsSouthfield, Michigan