Post-Approval Clinical Trial of the PCM® Cervical Disc

Completed · Phase 3

Conditions studied: Radiculopathy, Myelopathy

In brief

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.

Key facts

Study ID

NCT01905930

Run by

NuVasive

People needed

494

Starts

2013-04-01

Expected to finish

2015-04-01

Last updated by the study team

2015-05-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients enrolled in the PCM Cervical Disc IDE clinical study
• Patients willing and able to give informed consent

You may not qualify if…

• Patients considered failure during the PCM Cervical Disc IDE clinical study
• Patients who were withdrawn during the PCM Cervical Disc IDE clinical study

Where it is running

• Spine Group Beverly Hills — Beverly Hills, California, United States
• Denver Spine — Greenwood Village, Colorado, United States
• Midwest Orthopedic Associates at Rush — Chicago, Illinois, United States
• Chicago Back Institute — Chicago, Illinois, United States
• Goodman Campbell Brain and Spine — Indianapolis, Indiana, United States
• Towson Orthopedic Associates — Towson, Maryland, United States
• Wm. Beaumont Hospital — Southfield, Michigan, United States
• Columbia Orthopedic Research — Columbia, Missouri, United States
• Buffalo Spine Surgery — Lockport, New York, United States
• Institute for Spine Care — Syracuse, New York, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Neuroscience Specialists — Oklahoma City, Oklahoma, United States
• The Rothman Institute — Philadelphia, Pennsylvania, United States
• Scott and White Memorial Hospital — Temple, Texas, United States
• Virginia Brain and Spine — Winchester, Virginia, United States
• Olympia Othopaedic Associates — Olympia, Washington, United States
• Madigan Army Medical Center — Tacoma, Washington, United States
• NeuroSpine Center of Wisconsin — Appleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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