Cervical Disc Arthroplasty with Prestige LP Disc Versus Anterior Cervical Discectomy and Fusion: Seven-Year Outcomes

Cervical degenerative disc disease 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 [(e.g., pain, functional deficit, and/or neurological deficit radiographic studies (e.g., CT, MRI, x-rays, etc.)]:

herniated disc

osteophyte formation

One level requiring surgical treatment

C3-C4 disc to C6-C7 disc level of involvement

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

No previous surgical intervention at the involved level or any subsequent, planned/staged surgical procedure at the involved or adjacent level(s)

Is at least 18 years of age, inclusive, at the time of surgery

Preoperative Neck Disability Index score ≥30

Has a preoperative neck pain score of ≥20 based on the Preoperative Neck and Arm Pain Questionnaire

If a female of child-bearing potential, patient is not pregnant, at the time of surgery

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

Has a cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level;

Documented or diagnosed cervical instability defined by dynamic (flexion/extension) radiographs showing:

Sagittal plane translation > 3.5 mm or

Sagittal plane angulation > 20°

More than one cervical level requiring surgical treatment

Has a fused level adjacent to the level to be treated

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

Previous surgical intervention at the involved level

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 risk factors, a bone density scan will be required to determine eligibility):

• Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds

• Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.

Male over the age of 70

Male over the age of 60 that has sustained a non-traumatic hip or spine fracture

If the level of BMD is a T score of -3.5 or lower (i.e., -3.6, -3.7, etc.) or a T score of -2.5 or lower (i.e., -2.6, -2.7, etc.) 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 severe insulin dependent diabetes

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

Has fever (temperature > 101°F oral) at the time of surgery

Has a documented allergy 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

Has received drugs which 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 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), excluding 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 Artificial Cervical Disc-LP implantation