Post-Approval Clinical Trial of the PCM® Cervical Disc

May 19, 2015 updated by: NuVasive

A Prospective, Randomized, Multi-Center, Post-Approval Clinical Trial Evaluating the Long-Term (7 Year) Safety and Effectiveness 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

494

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90212
        • Spine Group Beverly Hills
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Denver Spine
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Midwest Orthopedic Associates at Rush
      • Chicago, Illinois, United States, 60625
        • Chicago Back Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Goodman Campbell Brain and Spine
    • Maryland
      • Towson, Maryland, United States, 21204
        • Towson Orthopedic Associates
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Wm. Beaumont Hospital
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Columbia Orthopedic Research
    • New York
      • Lockport, New York, United States, 14094
        • Buffalo Spine Surgery
      • Syracuse, New York, United States, 13202
        • Institute for Spine Care
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Neuroscience Specialists
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • The Rothman Institute
    • Texas
      • Temple, Texas, United States, 76508
        • Scott and White Memorial Hospital
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Virginia Brain and Spine
    • Washington
      • Olympia, Washington, United States, 98502
        • Olympia Othopaedic Associates
      • Tacoma, Washington, United States, 98431-1100
        • Madigan Army Medical Center
    • Wisconsin
      • Appleton, Wisconsin, United States, 54913
        • NeuroSpine Center of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NuVasive

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (ESTIMATE)

July 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUVA-PCM-1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Radiculopathy

Clinical Trials on PCM Cervical Disc

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe