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

A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease

The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.

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