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This prospective registry was designed as an observational study to ascertain how commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.
This multicenter prospective patient registry was developed with the aim of documenting how spine and neurosurgeons are utilizing the NanoBone products along with relevant patient outcomes. These outcomes include radiographic measures such as fusion outcome, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.
The primary objective of this study is to document and analyze the use of NanoBone products in spine fusion surgery (as a stand-alone bone graft, or in combination with local bone only, no other BGS or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spine Fusion using NanoBone | All patients in the study will be drawn from the individual surgeons' practice. Patients will be candidates for spinal fusion surgery after having failed conservative treatment or will have had spinal fusion surgery but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoBone Bone Graft Substitute | Other | Synthetic, biodegradable bone grafting material that is composed of non-sintered nanocrystalline hydroxyapatite (HA) which is embedded in a silica gel matrix (amorphous SiO2). The ratio of HA/SiO2 has been chosen to optimize the rate of biodegradation for treatment of osseous defects in human bone. NanoBone does not contain any components of animal or human origin, eliminating the possibility of transmission of infection or disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Success | Evidence of bony bridging between vertebral endplates and/or transverse processes of bone grafted vertebrae or absence of motion between vertebral bodies or both. | 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | Occurrence of Complications or Adverse Events | 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | Improvement from baseline in Visual Analog Scale (VAS) pain score (0= no pain, 10=worst possible pain) | 12-months |
| Function | Improvement from baseline in Oswestry Disability Index (ODI) or Neck Disability Index (NDI) Scale (0=no disability-100=totally disabled) |
Inclusion Criteria:
Exclusion Criteria:• Severe vascular or neurological disease
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All patients in the study will be drawn from the individual surgeons' practice. Patients will be candidates for spinal fusion surgery after having failed conservative treatment or will have had spinal fusion surgery but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient. The choice of a NanoBone product is or was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.
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| Name | Affiliation | Role |
|---|---|---|
| Jim Cassidy, PhD | Artoss Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoArizona | Chandler | Arizona | 85226 | United States | ||
| Sonoran Spine |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013121 | Spinal Curvatures |
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| 12-months |
| Tempe |
| Arizona |
| 85281 |
| United States |
| SENTA Clinic | San Diego | California | 92108 | United States |
| Hartford Health Care | Hartford | Connecticut | 06102 | United States |
| OrthoBethesda | Bethesda | Maryland | 20817 | United States |
| Sam Shamsnia MD Neurosurgery | Biloxi | Mississippi | 39532 | United States |