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
1 other identifier
interventional
494
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2013
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 18, 2013
CompletedFirst Posted
Study publicly available on registry
July 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 21, 2015
May 1, 2015
2 years
July 18, 2013
May 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
7 years
Study Arms (2)
PCM Cervical Disc
EXPERIMENTALPatients 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
Ant. Cervical Discectomy & Fusion(ACDF)
ACTIVE COMPARATORPatients 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients enrolled in the PCM Cervical Disc IDE clinical study
- Patients willing and able to give informed consent
You may not qualify if:
- Patients considered failure during the PCM Cervical Disc IDE clinical study
- Patients who were withdrawn during the PCM Cervical Disc IDE clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NuVasivelead
Study Sites (18)
Spine Group Beverly Hills
Beverly Hills, California, 90212, United States
Denver Spine
Greenwood Village, Colorado, 80111, United States
Midwest Orthopedic Associates at Rush
Chicago, Illinois, 60612, United States
Chicago Back Institute
Chicago, Illinois, 60625, United States
Goodman Campbell Brain and Spine
Indianapolis, Indiana, 46260, United States
Towson Orthopedic Associates
Towson, Maryland, 21204, United States
Wm. Beaumont Hospital
Southfield, Michigan, 48034, United States
Columbia Orthopedic Research
Columbia, Missouri, 65201, United States
Buffalo Spine Surgery
Lockport, New York, 14094, United States
Institute for Spine Care
Syracuse, New York, 13202, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Neuroscience Specialists
Oklahoma City, Oklahoma, 73120, United States
The Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Virginia Brain and Spine
Winchester, Virginia, 22601, United States
Olympia Othopaedic Associates
Olympia, Washington, 98502, United States
Madigan Army Medical Center
Tacoma, Washington, 98431-1100, United States
NeuroSpine Center of Wisconsin
Appleton, Wisconsin, 54913, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2013
First Posted
July 23, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 21, 2015
Record last verified: 2015-05