Post-Approval Clinical Trial 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.

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Key information

Conditions

Radiculopathy Central Nervous System Diseases Myelopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Spinal Cord Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Spine Group Beverly Hills, Beverly Hills, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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Patients who were withdrawn during the PCM Cervical Disc IDE clinical study

Treatment and study plan

PCM Cervical Disc

Device

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

Anterior Cervical Discectomy and Fusion (ACDF)

Device

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

Primary outcomes

Individual Patient Overall Success

Time frame: 7 years
- 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

Sponsors and collaborators

Lead sponsor

NuVasive

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 23, 2013
Registry last updated: May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed