Radiculopathy Clinical Trial
Official title:
A Prospective, Randomized, Multi-Center, Post-Approval Clinical Trial Evaluating the Long-Term (7 Year) Safety and Effectiveness of the PCM® Cervical Disc
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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