Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD
Condition: Cervical Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Intervention: PRESTIGE® LP Cervical Disc; ATLANTIS Anterior Cervical Plate
Intervention description: The PRESTIGE® LP Cervical Disc was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.; Anterior cervical discectomy and fusion with ATLANTIS plate for control group
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cervical Disc

Summary:

      The purpose of this clinical trial is to evaluate the safety and effectiveness of the
      PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical
      degenerative disc disease at a single level from C3-C4 to C6-C7.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or
             myelopathy with at least one of the following items producing symptomatic nerve root
             and/or spinal cord compression that is documented by patient history: a) herniated
             disc; b) osteophyte formation

          -  One level requiring surgical treatment

          -  C3-C4 disc to C6-C7 disc level involvement

          -  Unresponsive to non-operative treatment for six weeks or presence of progressive
             symptoms or signs of cord compression

          -  No previous surgical procedures at the involved level or any planned surgical
             procedure at the involved or adjacent level.

          -  Preop Neck Disability index score ≥ 30

          -  Preop Neck Pain score of ≥ 20 based on the Preop Neck & Arm Pain Questionnaire

          -  Not pregnant at time of surgery

          -  Willing and able to comply with study plan and able to understand and sign patient
             informed consent

        Exclusion Criteria:

          -  Any other cervical spinal condition requiring surgical treatment at the involved level

          -  Documented or diagnosed cervical instability defined by radiographs showing

               1. Sagittal plane translation > 3.5mm or

               2. Sagittal plane angulation > 20 degrees.

          -  More than one cervical level requiring surgery

          -  A fused level adjacent to the level to be treated

          -  Severe pathology of the facet joint of involved bodies

          -  Previous surgery at the involved level

          -  Previously diagnosed osteopenia or osteomalacia

          -  Any of the following that may be associated with an osteoporosis diagnosis (if "Yes"
             to any of these, a DEXA Scan will be required to determine eligibility)

               1. Postmenopausal non-Black female over 60 years of age and weighs less than 140
                  pounds

               2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist
                  fracture

               3. Male over the age of 70

               4. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.

        If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or
        lower with the vertebral crush fracture, then the patient is excluded.

          -  Presence of spinal metastases

          -  Overt or active bacterial infection, either local or systemic

          -  Severe insulin dependent diabetes

          -  Chronic or acute renal failure or history of renal disease

          -  Temperature > 101º F oral at surgery

          -  Documented allergy to stainless steel, titanium or a titanium alloy

          -  Mentally incompetent

          -  Is a prisoner

          -  Is pregnant

          -  Is an alcohol and/or drug abuser

          -  Has received drugs which may interfere with bone metabolism within 2 weeks prior to
             the planned surgery date (steroids, methotrexate), excluding routine preop
             anti-inflammatories)

          -  A history of endocrine or metabolic disorder known to affect osteogenesis

          -  A condition that requires postop medications that interfere with the stability of the
             implant (steroids). This does not include low dose aspirin therapy.

          -  Received treatment with an investigational therapy within 28 days prior to surgery or
             planned for 16 weeks following implantation.