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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01905930

Enrollment

494

Registered

2013-07-23

Start date

2013-04-30

Completion date

2015-04-30

Last updated

2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelopathy, Radiculopathy

Brief 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.

Interventions

DEVICEPCM 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

DEVICEAnterior 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Individual Patient Overall Success	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026