Post-Approval Clinical Trial of the PCM® Cervical Disc

Study Overview
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Brief Summary
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On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.

Detailed Description
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A prospective, multi-center, post approval study with concurrent control group consisting of those patients that were enrolled and did not fail in the PCM Cervical Disc IDE clinical study and will to give consent to participate. All of the PCM IDE investigational sites who have active patients will be chosen to participate in this study. All patients who are actively participating in the pivotal IDE study will be asked to participate in this study. The study consists of follow-up periods only. The follow-up period will last for seven years from each patient's surgery date.

Official Title
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A Prospective, Randomized, Multi-Center, Post-Approval Clinical Trial Evaluating the Long-Term (7 Year) Safety and Effectiveness of the PCM® Cervical Disc

Conditions
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Radiculopathy, Myelopathy

Intervention / Treatment
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* Device: PCM Cervical Disc
* Device: Anterior Cervical Discectomy and Fusion (ACDF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients enrolled in the PCM Cervical Disc IDE clinical study Patients willing and able to give informed consent Exclusion Criteria: Patients considered failure during the PCM Cervical Disc IDE clinical study Patients who were withdrawn during the PCM Cervical Disc IDE clinical study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCM Cervical Disc<br>Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1 | Device: PCM Cervical Disc<br>* Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1<br>|
| Active Comparator: Ant. Cervical Discectomy & Fusion(ACDF)<br>Patients enrolled in the IDE clinical study and treated with an anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1 | Device: Anterior Cervical Discectomy and Fusion (ACDF)<br>* Patients enrolled in the IDE clinical study and treated with an anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual Patient Overall Success | Improvement of at least 20% on the Neck Disability Index (NDI) at 7 years compared to baseline No device failures requiring revision, reoperation, removal or supplemental fixation No major complications such as vascular or neurological injury Radiographic success | 7 years |