search
Back to results

Post-Approval Clinical Trial of the PCM® Cervical Disc

Primary Purpose

Radiculopathy, Myelopathy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PCM Cervical Disc
Anterior Cervical Discectomy and Fusion (ACDF)
Sponsored by
NuVasive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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  • Patients who were withdrawn during the PCM Cervical Disc IDE clinical study

Sites / Locations

  • Spine Group Beverly Hills
  • Denver Spine
  • Midwest Orthopedic Associates at Rush
  • Chicago Back Institute
  • Goodman Campbell Brain and Spine
  • Towson Orthopedic Associates
  • Wm. Beaumont Hospital
  • Columbia Orthopedic Research
  • Buffalo Spine Surgery
  • Institute for Spine Care
  • The Cleveland Clinic
  • Neuroscience Specialists
  • The Rothman Institute
  • Scott and White Memorial Hospital
  • Virginia Brain and Spine
  • Olympia Othopaedic Associates
  • Madigan Army Medical Center
  • NeuroSpine Center of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCM Cervical Disc

Ant. Cervical Discectomy & Fusion(ACDF)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Individual Patient Overall Success
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

Secondary Outcome Measures

Full Information

First Posted
July 18, 2013
Last Updated
May 19, 2015
Sponsor
NuVasive
search

1. Study Identification

Unique Protocol Identification Number
NCT01905930
Brief Title
Post-Approval Clinical Trial of the PCM® Cervical Disc
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NuVasive

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Myelopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
494 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCM Cervical Disc
Arm Type
Experimental
Arm Description
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
Arm Title
Ant. Cervical Discectomy & Fusion(ACDF)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
PCM Cervical Disc
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Anterior Cervical Discectomy and Fusion (ACDF)
Intervention Description
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 Measure Information:
Title
Individual Patient Overall Success
Description
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
Time Frame
7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Spine Group Beverly Hills
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Denver Spine
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Midwest Orthopedic Associates at Rush
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Back Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
Goodman Campbell Brain and Spine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Towson Orthopedic Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Wm. Beaumont Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Columbia Orthopedic Research
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Buffalo Spine Surgery
City
Lockport
State/Province
New York
ZIP/Postal Code
14094
Country
United States
Facility Name
Institute for Spine Care
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Neuroscience Specialists
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
The Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Virginia Brain and Spine
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Olympia Othopaedic Associates
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-1100
Country
United States
Facility Name
NeuroSpine Center of Wisconsin
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54913
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nuvasive.com
Description
Related Info

Learn more about this trial

Post-Approval Clinical Trial of the PCM® Cervical Disc

We'll reach out to this number within 24 hrs