NCT01905930

Post-Approval Clinical Trial of the PCM® Cervical Disc

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Radiculopathy
• Myelopathy

Interventions

Type	Name	Description
DEVICE	PCM Cervical Disc	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	Anterior Cervical Discectomy and Fusion (ACDF)	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

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-07-23
• Last updated: 2015-05-21

Locations

18 sites across 1 country: United States