Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective registry was designed as an observational study to ascertain how commercially available NanoBone products are being used by surgeons performing foot and ankle surgery which involves bone grafting, as well as determining relevant patient outcomes.
This multicenter prospective patient registry was developed with the aim of documenting how surgeons are utilizing NanoBone products in foot and ankle surgery along with relevant patient outcomes. These outcomes include radiographic measures such as fusion or graft consolidation success, 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 foot and ankle surgery (as a stand-alone bone graft, no other local bone, autograft, bone graft substitute, or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foot and Ankle Surgery using NanoBone | All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already scheduled for foot and ankle surgery after having failed conservative treatment, or will have had foot and ankle surgery using NanoBone products 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, as well as the surgery, 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. |
|
| 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 | Fusion/Graft Consolidation: Evidence of bony (osseous) bridging between the graft material and the patient's bone in the segment requiring fusion or reconstruction. | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | Occurrence of Complications or Adverse Events | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | Change from baseline in Visual Analog Scale (VAS) pain score (0=no pain, 10=worst possible pain | 6-months |
| Function | Change from baseline in Foot and Ankle Ability Measure (FAAM) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already scheduled for foot and ankle surgery after having failed conservative treatment, or will have had foot and ankle surgery using NanoBone products 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, as well as the surgery, 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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jim Cassidy, PhD | Artoss Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Foot and Ankle Institute | Scottsdale | Arizona | 85251 | United States | ||
| Florida Orthopedic Foot & Ankle Center |
Not provided
| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 6-months |
| Sarasota |
| Florida |
| 34239 |
| United States |
| Illinois Orthopedic Institute | Joliet | Illinois | 60435 | United States |
| Morrison Hospital | Morrison | Illinois | 61270 | United States |
| Podiatry Associates of Indiana | Indianapolis | Indiana | 46254 | United States |
| Hoosier Foot and Ankle | Kokomo | Indiana | 46901 | United States |
| The Iowa Clinic | West Des Moines | Iowa | 50266 | United States |
| Orthopedic Associates of Duluth | Duluth | Minnesota | 55805 | United States |