An Assessment of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) to Determine Superiority to ANterior Cervical Discectomy and Fusion (ACDF) in the Treatment of 2-Level Cervical Degenerative Disease
Providence Medical Technology, Inc.
Summary
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.
Description
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 toge…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At least 18 years of age (Skeletally Mature) * Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 2 contiguous levels as determined by the following: 1. 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. 2. radiographically determined pathology at the levels to be treated correlating to prim…
Interventions
- DeviceCircumferential Cervical Fusion (CCF)
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).
- ProcedureAnterior Cervical Discectomy and Fusion
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.
Location
- The Orthopaedic InstitutePaducah, Kentucky