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| ID | Type | Description | Link |
|---|---|---|---|
| WIRB Protocol #20061453 |
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The purpose of this study is to compare the safety and efficacy of Preservon(TM) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy.
Patient follow-up will be conducted at 6 weeks, 3 months, and 6 months. At 3 months after surgery, the implanted bone dowels will be assessed for subsidence; at 6 months after surgery, the implanted bone dowels will be assessed for fusion. Patients will complete questionnaires and x-rays taken at each visit.
The degree of subsidence and rate of fusion will be assessed based on the evaluation of the x-rays taken. The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the type of treatment that each patient has received.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preservon | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Cervical Discectomy and Fusion | Procedure | 1,2,3,or 4 level surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of subsidence | 3 months post-op | |
| Rate of fusion | 6 months post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce E. Mathern, M.D. | VCU Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VCU Medical Center | Richmond | Virginia | 23298-0631 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25360528 | Result | Graham RS, Samsell BJ, Proffer A, Moore MA, Vega RA, Stary JM, Mathern B. Evaluation of glycerol-preserved bone allografts in cervical spine fusion: a prospective, randomized controlled trial. J Neurosurg Spine. 2015 Jan;22(1):1-10. doi: 10.3171/2014.9.SPINE131005. |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D013118 | Spinal Cord Diseases |
| D007714 | Klippel-Feil Syndrome |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
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| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |