LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

Study Overview
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Brief Summary
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The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device. The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels. Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nerve/spinal cord compression despite continued non-operative conservative treatment.

Detailed Description
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Objectives of the Investigation The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device. The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels. Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nerve/spinal cord compression despite continued non-operative conservative treatment. Study Design Rationale The study is a prospective, randomized, multi-center, concurrently controlled investigation, in which the study device will be compared to the control treatment consisting of conventional anterior cervical discectomy and fusion (ACDF) in accordance with the Smith-Robinson procedure. Patients will be followed for two years postsurgery (primary endpoint) and at 3, 4, 5, and 7 years thereafter. Duration of the Investigation Patients will be followed post-operatively at 6 weeks, and 3-, 6-, 12-, 18-, and 24-months. After 24 months, patients will continue to be followed at 3,4, 5 and 7 years. Design Techniques to Avoid Bias To eliminate selection bias, investigational and control comparison groups will be assigned at random. Institutional Review Board No clinical studies will begin without documented approval of the clinical investigation by the Institutional Review Board (IRB) affiliated with the study center.

Official Title
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LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: Cervical Artificial Disc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-69 years. Diagnosis of radiculopathy or myeloradiculopathy 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: Neck and/or arm pain (at least 30mm on the 100mm VAS scale). Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale. Abnormal sensation including hyperesthesia or hypoesthesia; and/or Abnormal reflexes Symptomatic at one or two adjacent levels from C3 to C7; Radiographically determined pathology at one or two adjacent level(s) to be treated correlating to primary symptoms including at least one of the following: Decreased disc height on radiography, CT, or MRI in comparison to a normal adjacent disc. Degenerative spondylosis on CT or MRI. Disc herniation on CT or MRI; Neck Disability Index Score of ≥15/50 or ≥30%; Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for: Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment. Note: Not a complete listing Exclusion Criteria: Reported to have an active systemic infection or infection at the operative site; Reported to have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C; More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic spontaneous fusions; Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury; Reported to have had any prior spine surgery at the operative level; Reported to have had prior cervical fusion procedure at any level; Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention; Disc height less than 3mm as measured from the center of the disc in a neutral position and disc height less than 20% of the anterior-posterior width of the inferior vertebral body; Radiographic confirmation of severe facet joint disease or degeneration; Note: Not a complete listing

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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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Level<br>Cervical artificial disc (investigational device) at 1 level compared with control procedure (ACDF) at one level | Device: Cervical Artificial Disc<br>* Cervical artificial disc mechanical device<br>|
| Experimental: 2 Level<br>Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels | Device: Cervical Artificial Disc<br>* Cervical artificial disc mechanical device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Definition of Study Success | An individual subject in either treatment group was considered a success if the following criteria were met at 24 months: Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of >= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of <30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities. No study failures due to secondary surgical interventions at the index level Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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degenerative disc disease, cervical arthroplasty, Mobi C, multilevel, anterior cervical discectomy and fusion