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.
Study Type
OBSERVATIONAL
Enrollment
200
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.
Phoenix Foot and Ankle Institute
Scottsdale, Arizona, United States
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, United States
Illinois Orthopedic Institute
Joliet, Illinois, United States
Morrison Hospital
Morrison, Illinois, United States
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.
Time frame: 6-months
Safety Evaluation
Occurrence of Complications or Adverse Events
Time frame: 6-months
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Podiatry Associates of Indiana
Indianapolis, Indiana, United States
Hoosier Foot and Ankle
Kokomo, Indiana, United States
The Iowa Clinic
West Des Moines, Iowa, United States
Orthopedic Associates of Duluth
Duluth, Minnesota, United States