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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCM Cervical Disc | Experimental | 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) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCM Cervical Disc | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Individual Patient Overall Success |
| 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Group Beverly Hills | Beverly Hills | California | 90212 | United States | ||
| Denver Spine |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Anterior Cervical Discectomy and Fusion (ACDF) | Device | 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 |
|
| 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 |
| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D002493 | Central Nervous System Diseases |
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