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A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).
The clinical trial is to demonstrate that prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc prosthesis to treat symptomatic cervical disc disease (SCDD) in subjects at two contiguous levels from C3 to C7 who are unresponsive to conservative management. Subjects will be randomized in a 2:1 ratio to either the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). Subjects will be followed for at least 2 years and up to 5 years. Subjects will be required to complete subject questionnaires, have X-rays and undergo neurological assessments during the follow up visits as specified in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational | Experimental | Two-level prodisc C SK and/or prodisc C Vivo |
|
| Control | Active Comparator | Two-level Mobi-C device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prodisc C SK and/or Vivo | Device | Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). |
| Measure | Description | Time Frame |
|---|---|---|
| Composite clinical success rate of the two-level prodisc C SK and prodisc C Vivo will be no worse than marketed cervical disc prosthesis (Mobi-C) | Includes assessments such as NDI and neurological improvement. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Kuras | Centinel Spine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flagstaff Bone and Joint | Flagstaff | Arizona | 86001 | United States | ||
| Todd Lanman, MD, Inc. |
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multi-center, prospective, randomized, controlled comparison
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Patient is blinded to their treatment randomization until after surgery.
| Mobi-C Cervical Disc | Device | Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). |
|
| Beverly Hills |
| California |
| 90210 |
| United States |
| Doctors Outpatient Center for Surgery | Los Angeles | California | 90048 | United States |
| Sutter Health - Palo Alto Medical Foundation | Palo Alto | California | 94301 | United States |
| Sutter Health | Sacramento | California | 95816 | United States |
| HCA Healthcare | Lone Tree | Colorado | 80124 | United States |
| Sky Ridge Medical Center Campus | Lone Tree | Colorado | 80124 | United States |
| Center for Spine and Orthopedics, Scientific Education and Research Foundation | Thornton | Colorado | 80229 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| St. Vincent's Neurosurgery | Jacksonville | Florida | 32204 | United States |
| Kennedy-White Orthopaedic Center | Sarasota | Florida | 34232 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Florida Orthopaedic Institute | Temple Terrace | Florida | 33637 | United States |
| Indiana Spine Group | Carmel | Indiana | 46032 | United States |
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42003 | United States |
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| University Spine Center | Wayne | New Jersey | 07470 | United States |
| NYU Langone Orthopedic Hospital | New York | New York | 10003 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Northwell Health, Lenox Hill Hospital | New York | New York | 10075 | United States |
| Axis Neurosurgery and Spine | Williamsville | New York | 14221 | United States |
| M3-Emerging Medical Resarch | Durham | North Carolina | 27704 | United States |
| SVCMC Solon Medical - Northern Ohio Surgery Center | Beachwood | Ohio | 44122 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| DFW Center for Spinal Disorders | Fort Worth | Texas | 76132 | United States |
| Texas Back Institute | Plano | Texas | 75093 | United States |
| Texas Spine Care Center | San Antonio | Texas | 78231 | United States |
| The Disc Replacement Center | Salt Lake City | Utah | 84088 | United States |
| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D011843 | Radiculopathy |
| D013118 | Spinal Cord Diseases |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D002493 | Central Nervous System Diseases |
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