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.
Degenerative disc disease (DDD) of the neck occurs when the discs between the bones of the spine wear down over time. These discs normally act as cushions and help the neck move. When they break down, the space between the bones can narrow and put pressure on nearby nerves or the spinal cord. This can cause pain in the neck, shoulders, and arms. One common surgical treatment is called Anterior Cervical Discectomy and Fusion (ACDF). In this procedure, the surgeon approaches the spine from the front of the neck, removes the damaged disc, relieves pressure on the nerves, and fuses the bones together. Another option is Posterior Cervical Fusion (PCF), which is done from the back of the neck. In some cases, both procedures are combined to provide more stability and support healing. The purpose of this study is to evaluate whether combining ACDF and PCF leads to better outcomes than ACDF alone in patients with two-level cervical degenerative disc disease. Participants in this study will be assigned to one of two groups: One group will receive ACDF alone (standard treatment) The other group will receive a combination of ACDF and PCF (investigational treatment) The main goal of the study is to compare how well the bones fuse together in each group at 12 months after surgery. The study will assess whether the combined approach (ACDF + PCF) results in a higher rate of successful fusion compared to ACDF alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
225
Circumferential 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).
ACDF 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.
The Orthopaedic Institute
Paducah, Kentucky, United States
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.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.