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.
Study Type
OBSERVATIONAL
Enrollment
330
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.
OrthoArizona
Chandler, Arizona, United States
Sonoran Spine
Tempe, Arizona, United States
SENTA Clinic
San Diego, California, United States
Hartford Health Care
Hartford, Connecticut, United States
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.
Time frame: 12-months
Safety Evaluation
Occurrence of Complications or Adverse Events
Time frame: 12-months
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OrthoBethesda
Bethesda, Maryland, United States
Sam Shamsnia MD Neurosurgery
Biloxi, Mississippi, United States