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Post-Approval Clinical Trial of the PCM® Cervical Disc

NCT01905930 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2015-05-21

No results posted yet for this study

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.

Conditions

  • Radiculopathy
  • Myelopathy

Interventions

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

Sponsors & Collaborators

  • NuVasive

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905930 on ClinicalTrials.gov