The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF) procedures.
The primary outcome measure is the rate of fusion success in the investigational treatment arm (ACDF + PCF) compared with the control arm (ACDF alone) at the 12-month follow-up visit.
Researchers will compare the investigational treatment arm (ACDF + PCF) to the control arm (ACDF alone) to assess superiority in terms of fusion success rate.
At least 18 years of age (Skeletally Mature)
diagnosis of radiculopathy, myelopathy or myeloradiculopathy of the cervical spine, with pain, including at least one of the following: i. Neck and/or arm pain, ii. Decreased muscle strength, and iii. Abnormal sensation including hyperesthesia or hypoesthesia; and/or Abnormal reflexes.
radiographically determined pathology at the levels to be treated correlating to primary symptoms including at least one of the following: i. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc, ii. Degenerative spondylosis on MRI, and iii. Disc herniation on MRI.
NDI Score of ≥ 15/50
Has, in the Investigator's opinion, any disease or condition that would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity)
Active systemic infection or infection at the operative site
History of or anticipated treatment for active systemic infection, including HIV or Hepatitis C
Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury that may prevent device placement
Parallel
Circumferential Cervical Fusion (CCF)
DeviceCircumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF) performed during the same surgical procedure, irrespective of order. The PCF procedure is performed using CORUS™ Spinal System-X to access and prepare the joint for fusion, followed by placement of PCSS 3D and delivery of an allograft demineralized bone matrix (DBM).
Anterior Cervical Discectomy and Fusion
Procedure/SurgeryACDF is performed using standard instruments and completed with a titanium interbody implant and anterior semi-constrained plate. The plate is intended to stabilize the treated levels until fusion occurs.
Superiority in Fusion Success in Treatment Arm (CCF) Compared to Control Arm (ACDF)
Superiority in the rate of fusion success in the treatment arm (CCF) as compared to the control arm (ACDF) at the 12-month visit. An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across endplates at all levels treated with no re-intervention.
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