Outcome Study of Patients Treated With Translational Cervical Plate Used to Treat Degenerative Disc Disease

Prospective Multi-Center Clinical Study of Patients With Degenerative Disc Disease Treated With Anterior Cervical Decompression and Fusion Using the Vectra-T Translational Cervical Plate.

The purpose of this study is to measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease. The research part of this study is the answering of questionnaires by the patient concerning their quality of life, prior to, and after surgery.

This is a prospective, multi-center, four-arm study designed to evaluate the clinical and radiographic outcomes in patients diagnosed with cervical degenerative disc disease (DDD) and treated using the Vectra-T Cervical Plate and the Advanced ACF or CorticoCancellous Allograft Spacer made by Synthes Spine Company (Paoli, PA). This is not an investigational study (IDE) and no investigational or experimental devices or procedures are included in this study.

Inclusion Criteria:

• One to four levels (consecutive) cervical degenerative disc disease between C2 and C7, defined as at least one of the following:

  • disc herniation
  • axial neck pain (with or without radiculopathy or myelopathy) caused by spondylosis
  • functional deficit
  • neurological deficit which significantly limits patient's normal living

• One to four cervical levels to be plated

• Patient is skeletally mature and at least 18 years of age

• Patient signs consent form

• Patient is available for long term (24 month) follow-up

• Etiology must be confirmed by MRI or CT

Exclusion Criteria:

• Spondylolisthesis greater than grade 1 at either level(s) to be instrumented
• Indications for complete corpectomy of any involved levels
• Posterior instrumentation is necessary at same levels
• More than one previous failed anterior fusion attempt at the involved level(s)
• Has had more than one previous open, posterior, spine surgical procedures at the involved level(s) or pre-op instability on Flexion/Extension radiographs.
• Pregnant or interested in becoming pregnant during the study follow-up period
• Has a known sensitivity to device materials
• Mentally incompetent or prisoner
• Currently a participant in a study related to the treatment of cervical spinal disorders
• Pre-op instability>3mm on flexion/extension X-rays