Post-Approval Clinical Trial of the PCM® Cervical Disc
- Conditions
- RadiculopathyMyelopathy
- Interventions
- Device: PCM Cervical DiscDevice: Anterior Cervical Discectomy and Fusion (ACDF)
- Registration Number
- NCT01905930
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 494
- Patients enrolled in the PCM Cervical Disc IDE clinical study
- Patients willing and able to give informed consent
- Patients considered failure during the PCM Cervical Disc IDE clinical study
- Patients who were withdrawn during the PCM Cervical Disc IDE clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCM Cervical Disc 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 Ant. Cervical Discectomy & Fusion(ACDF) 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
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Wm. Beaumont Hospital
🇺🇸Southfield, Michigan, United States
Midwest Orthopedic Associates at Rush
🇺🇸Chicago, Illinois, United States
Chicago Back Institute
🇺🇸Chicago, Illinois, United States
Buffalo Spine Surgery
🇺🇸Lockport, New York, United States
Columbia Orthopedic Research
🇺🇸Columbia, Missouri, United States
Institute for Spine Care
🇺🇸Syracuse, New York, United States
The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Virginia Brain and Spine
🇺🇸Winchester, Virginia, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
Olympia Othopaedic Associates
🇺🇸Olympia, Washington, United States
Denver Spine
🇺🇸Greenwood Village, Colorado, United States
Towson Orthopedic Associates
🇺🇸Towson, Maryland, United States
Neuroscience Specialists
🇺🇸Oklahoma City, Oklahoma, United States
Goodman Campbell Brain and Spine
🇺🇸Indianapolis, Indiana, United States
Spine Group Beverly Hills
🇺🇸Beverly Hills, California, United States
The Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States
NeuroSpine Center of Wisconsin
🇺🇸Appleton, Wisconsin, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States