Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels

This clinical investigation is being conducted to evaluate the PRESTIGE-LP device's
performance at two adjacent cervical levels (C3-C7) in the treatment of patients with
symptomatic degenerative disc disease. One-half of the patients in this randomized pivotal
clinical trial will be treated at two adjacent cervical levels with the PRESTIGE-LP device.
The remaining patients will receive a bi-level anterior cervical discectomy and fusion with
cortical ring allografts and the ATLANTIS Cervical Plate System.

Inclusion Criteria:

- Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment &
involving intractable radiculopathy, myelopathy, or both

- Has a herniated disc and/or osteophyte formation at each level to be treated that is
producing symptomatic nerve root and/or spinal cord compression. The condition is
documented by patient history, and the requirement for surgical treatment is evidenced
by radiographic studies

- Unresponsive to non-operative treatment for approximately 6 weeks or has the presence
of progressive symptoms or signs of nerve root/spinal cord compression in the face of
continued non-operative management

- Has no previous surgical intervention at the involved levels or any subsequent
planned/staged surgical procedure at the involved or adjacent level(s)

- Must be ≥ 18 years; skeletally mature at time of surgery

- Preoperative NDI score ≥ 30

- Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain
Questionnaire

- If a female of childbearing potential, patient is non-pregnant, non-nursing, and
agrees not to become pregnant during the study period

- Is willing to comply with the study plan and sign Patient Informed Consent Form

Exclusion Criteria:

- Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical
treatment at the involved levels

- Has documented or diagnosed cervical instability relative to adjacent segments at
either level, defined by dynamic (flexion/extension) radiographs showing: Sagittal
plane translation > 3.5 mm, or Sagittal plane angulation > 20 degrees.

- Has more than two cervical levels requiring surgical treatment

- Has a fused level adjacent to the levels to be treated

- Has severe pathology of the facet joints of the involved vertebral bodies

- Has had previous surgical intervention at either one or both of the involved levels or
at adjacent levels

- Has been previously diagnosed with osteopenia or osteomalacia

- Has any of the following that may be associated with a diagnosis of osteoporosis (If
"Yes" to any of the below a DEXA Scan will be required to determine eligibility.)

- Postmenopausal non-Black female over age of 60 who weighs < 140 pounds

- Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist
fracture

- Male > 70 years

- Male > 60 years who has sustained a non-traumatic hip or spine fracture

- If the level of BMD is a T score of -3.5 or lower or a T score of -2.5 or lower
with vertebral crush fracture, then the patient is excluded from the study

- Has presence of spinal metastases

- Has overt or active bacterial infection, either local or systemic

- Has insulin dependent diabetes

- Is a tobacco user who does not agree to suspend smoking prior to surgery

- Has chronic or acute renal failure or prior history of renal disease

- Has a documented allergy or intolerance to stainless steel, titanium, or a titanium
alloy

- Is mentally incompetent (If questionable, obtain psychiatric consult)

- Is a prisoner

- Is pregnant

- Is an alcohol and/or drug abuser as defined by currently undergoing treatment for
alcohol and/or drug abuse

- Is involved with current or pending litigation regarding a spinal condition

- Has received drugs that may interfere with bone metabolism within two weeks prior to
the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine
perioperative anti-inflammatory drugs

- Has a history of an endocrine or metabolic disorder known to affect osteogenesis
(e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis
imperfecta)

- Has a condition that requires postoperative medications that interfere with the
stability of the implant, such as steroids. (This does not include low-dose aspirin
for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs.)

- Has received treatment with an investigational therapy within 28 days prior to
implantation surgery or such treatment is planned during the 16 weeks following
implantation