Post-Approval Clinical Trial of the PCM® Cervical Disc
Public ClinicalTrials.gov record NCT01905930. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01905930
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 494 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2013
- Primary completion
- Mar 31, 2015
- Completion
- Mar 31, 2015
- Last update posted
- May 20, 2015
2013 – 2015
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spine Group Beverly Hills | Beverly Hills | California | 90212 | — |
| Denver Spine | Greenwood Village | Colorado | 80111 | — |
| Midwest Orthopedic Associates at Rush | Chicago | Illinois | 60612 | — |
| Chicago Back Institute | Chicago | Illinois | 60625 | — |
| Goodman Campbell Brain and Spine | Indianapolis | Indiana | 46260 | — |
| Towson Orthopedic Associates | Towson | Maryland | 21204 | — |
| Wm. Beaumont Hospital | Southfield | Michigan | 48034 | — |
| Columbia Orthopedic Research | Columbia | Missouri | 65201 | — |
| Buffalo Spine Surgery | Lockport | New York | 14094 | — |
| Institute for Spine Care | Syracuse | New York | 13202 | — |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Neuroscience Specialists | Oklahoma City | Oklahoma | 73120 | — |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | — |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | — |
| Virginia Brain and Spine | Winchester | Virginia | 22601 | — |
| Olympia Othopaedic Associates | Olympia | Washington | 98502 | — |
| Madigan Army Medical Center | Tacoma | Washington | 98431-1100 | — |
| NeuroSpine Center of Wisconsin | Appleton | Wisconsin | 54913 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01905930, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 20, 2015 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01905930 live on ClinicalTrials.gov.