An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine

Study Overview
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Brief Summary
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This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. The information obtained from this clinical investigation will be used to support the post market surveillance for a PMA supplement for the PRESTIGE LP™ Cervical Disc implanted at two contiguous levels.

Official Title
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An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine

Conditions
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Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy

Intervention / Treatment
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* Device: PRESTIGE LP™ Cervical Disc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient must meet all of the following inclusion criteria to participate in this study: Has cervical degenerative disc disease at two (2) contiguous cervical levels (from C3 to C7) requiring surgical treatment and 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 (e.g., neck and/or arm pain, functional deficit and /or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.); Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative therapy; Has no previous surgical intervention at the involved levels or any other planned/staged surgical procedure at the involved levels; Has preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire; Must be at least 18 years of age and be skeletally mature at the time of surgery; 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 the Patient Informed Consent Form. Exclusion Criteria: A patient will be excluded from participating in this study for any of the following reasons: Has a cervical spine condition other than symptomatic cervical degenerative disease requiring surgical treatment at the involved levels; Has documented or diagnosed cervical instability relative to contiguous segments at either level, defined by dynamic (flexion/extension) radiographs showing: Sagittal plane translation > 3.5 mm, or Sagittal plane angulation > 20° Has more than two cervical levels requiring surgical treatment; 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; 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 DEXA Scan will be required to determine eligibility.): . Postmenopausal non-Black female over 60 years of age who weighs less than 140 pounds. Postmenopausal female who has sustained a non-traumatic hip, spine or wrist fracture. Male over the age of 70. Male over the age of 60 who 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 chronic or acute renal failure or prior history of renal disease; Has a documented allergy or intolerance to titanium, or a titanium alloy; Is mentally incompetent. (If questionable, obtain psychiatric consult); Is a prisoner; Is pregnant; 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 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. Is currently taking or has had chronic usage of certain prescription medications (e.g., Cloxacillin, an antibiotic used for prophylaxis against surgical infections, and/or Clotrimazole).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRESTIGE LP<br>Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. | Device: PRESTIGE LP™ Cervical Disc<br>* The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of Titanium, Vanadium, and Aluminum in the blood serum | The concentrations of Titanium, Vanadium, and Aluminum at different time points will be summarized using mean, standard deviation, median, minimum and maximum. | preoperative, 6 weeks, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall success | The patients enrolled in the study who receive the PRESTIGE LP™ Cervical Disc at two contiguous levels will be considered an overall success if the following criteria are met: NDI score improvement of at least 15 points from baseline; Maintenance or improvement in neurological status; No serious AE classified as implant associated/related or implant/surgical procedure associated/related; No secondary surgical procedure classified as a failure. | 3, 6, and 12 months | 
| NDI success | The self-administered Neck Disability Index (NDI) Questionnaire (Vernon and Mior, 1996) will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score > 15 | 3, 6, and 12 months | 
| Neck pain and Arm pain | Numerical rating scales adapted in part from Measuring Health (McDowell and Newell, 1996) will be used to evaluate neck pain and arm pain. The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales. | 3, 6, and 12 months | 
| Neurological success | Neurological status is based on motor function, sensory function, and reflexes. Each of the categories is comprised of a number of elements. Postoperative evaluations of each element will be compared to the preoperative evaluations. Success will be defined as maintenance or improvement in each element for the time period evaluated. | 3, 6, and 12 months | 
| Adverse Events (AE) | An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom, or disease temporally associated with the use of a product, whether or not considered related to the product(s) under study. This definition includes events related to the procedures involved and/or worsening of pre-existing conditions. | 3, 6, and 12 months | 
| Secondary surgery at index level | Some AEs or treatment failures may lead to a secondary surgical intervention at an operated index level. All patients undergoing a secondary surgical intervention at any operated index level will be followed. | 3, 6, and 12 months |