Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Approval Clinical Trial of the PCM® Cervical Disc

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01905930
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
NuVasive

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.


Condition or disease Intervention/treatment Phase
Radiculopathy Myelopathy Device: PCM Cervical Disc Device: Anterior Cervical Discectomy and Fusion (ACDF) Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multi-Center, Post-Approval Clinical Trial Evaluating the Long-Term (7 Year) Safety and Effectiveness of the PCM® Cervical Disc
Study Start Date : April 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: 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: 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

Active Comparator: Ant. Cervical Discectomy & 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
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905930


Locations
Show Show 18 study locations
Sponsors and Collaborators
NuVasive
Additional Information:
Layout table for additonal information
Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT01905930    
Other Study ID Numbers: NUVA-PCM-1101
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Radiculopathy
Spinal Cord Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Central Nervous System Diseases