PCM Cervical Disc System
Public ClinicalTrials.gov record NCT00578812. 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, Controlled Clinical Investigation Comparing PCM® Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: 2 Year Results From the US IDE Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.
Study identification
- NCT ID
- NCT00578812
- 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
- Jan 2005 (Type not available)
- Primary completion
- Mar 2010 (Actual)
- Completion
- Aug 2014 (Actual)
- Last update posted
- Jul 7, 2015
2005 – 2014
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tower Orthopedics | Beverly Hills | California | 90211 | — |
| Spine Group Beverly Hills | Beverly Hills | California | 90212 | — |
| Denver Spine | Greenwood Village | Colorado | 80111 | — |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | — |
| 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 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| 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 | — |
| OrthoNeuro | Westerville | Ohio | 43054 | — |
| Neuroscience Specialists | Oklahoma City | Oklahoma | 73120 | — |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | — |
| Neurosurgical Associates of San Antonio | San Antonio | Texas | 78229 | — |
| 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 NCT00578812, 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 Jul 7, 2015 · Synced Oct 22, 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 public registry record, listed eligibility criteria, and available contact information for NCT00578812 live on ClinicalTrials.gov.