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This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels. These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any other biologic product, during their ACDF operation. The ACDF procedure will be conducted with a radiolucent graft containment device such that progression of fusion can be adequately assessed via radiograph. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).
A total of 175 subjects will be selected for enrollment in this study from multiple centers. The subjects will have degenerative conditions in the cervical spine and will be undergoing ACDF surgery as treatment at one or two levels. The following eligibility criteria are designed to select subjects for whom protocol treatment is considered appropriate. All relevant medical and non-medical conditions should be taken into consideration when deciding whether this protocol is suitable for a particular subject.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biologic - Osteocel Plus | Biological | Osteocel Plus |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects. | from pre-op to 24-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP). | from pre-op to 24-month follow-up | |
| To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain). |
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Inclusion Criteria:
Exclusion Criteria:
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Existing clinic patients
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| Name | Affiliation | Role |
|---|---|---|
| Kelli Howell, MS | NuVasive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiley Center for Orthopaedic, Scripps Green Hospital | La Jolla | California | 92037 | United States | ||
| Stanford University |
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| Label | URL |
|---|---|
| NuVasive, Inc. | View source |
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| from pre-op to 24-month post-op |
| To evaluate and compare each outcome with respect to surgical time and blood loss. | from pre-op to 24-month follow-up |
| Redwood City |
| California |
| 94063 |
| United States |
| UCSD Department of Orthpaedic Surgery, UCSD Medical Center | San Diego | California | 92103 | United States |
| The Spine Institute, St. John's Health Center | Santa Monica | California | 90404 | United States |
| University of South Florida Department of Neurosurgery, Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Pinnacle Orthopaedics, Wellstone Kennestone Hospital | Marietta | Georgia | 30060 | United States |
| Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center | Joliet | Illinois | 60435 | United States |
| Indiana Center for NeuroSurgery, Indiana Surgery Center East | Indianopolis | Indiana | 46219 | United States |
| Columbia Orthopaedic Group, Boone Hospital Center | Columbia | Missouri | 65201 | United States |
| NWREI (for Ortho Montana) | Billings | Montana | 59101 | United States |
| Buffalo Spine Surgery, Kenmore Mercy | Lockport | New York | 14094 | United States |
| Duke University Medical Center | Durham | North Carolina | 27708 | United States |
| The Center for Advanced Orthopaedics, Adena Bone and Joint Center | Chillicothe | Ohio | 45601 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19106 | United States |
| Spine Team Texas, Texas Health Harris Methodist Hospital Southlake | Southlake | Texas | 76092 | United States |
| Winchester Medical Center | Winchester | Virginia | 22601 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |