2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C

Study Overview
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Brief Summary
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A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).

Detailed Description
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The clinical trial is to demonstrate that prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc prosthesis to treat symptomatic cervical disc disease (SCDD) in subjects at two contiguous levels from C3 to C7 who are unresponsive to conservative management. Subjects will be randomized in a 2:1 ratio to either the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). Subjects will be followed for at least 2 years and up to 5 years. Subjects will be required to complete subject questionnaires, have X-rays and undergo neurological assessments during the follow up visits as specified in the protocol.

Official Title
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A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)

Conditions
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Symptomatic Cervical Disc Disease

Intervention / Treatment
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* Device: prodisc C SK and/or Vivo
* Device: Mobi-C Cervical Disc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and ≤69 years. Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following: Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7. Radiographically determined pathology at the level to be treated correlating to primary symptoms. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) Exclusion Criteria: Have more than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic spontaneous fusions. Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury. Have had a prior cervical TDR or fusion procedure at any level. Have osteoporosis or is at increased risk of osteoporosis Have active malignancy that included a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least 5 years. Have known allergies to cobalt, chromium, molybdenum, titanium, nickel or polyethylene. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system. Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids. Have a Body Mass Index (BMI) > 40 kg/m2. Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents). Have a current history of heavy smoking (more than one pack of cigarettes per day).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multi-center, prospective, randomized, controlled comparison
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational<br>Two-level prodisc C SK and/or prodisc C Vivo | Device: prodisc C SK and/or Vivo<br>* Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).<br>|
| Active Comparator: Control<br>Two-level Mobi-C device | Device: Mobi-C Cervical Disc<br>* Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite clinical success rate of the two-level prodisc C SK and prodisc C Vivo will be no worse than marketed cervical disc prosthesis (Mobi-C) | Includes assessments such as NDI and neurological improvement. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptomatic cervical disc disease, SCDD, neck pain, radiculopathy, myelopathy, cervical spine pain, neck surgery, cervical surgery, arm numbness, hand numbness, arm tingling, hand tingling, arm weakness