This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.
This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, 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 acute trauma cases (as a stand-alone bone graft, or in combination with local bone only, no other 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
The surgical technique used by the surgeon and the choice of the specific NanoBone product is or was determined solely by the surgeon and is independent of this observational study.
SSM Health St. Mary's Hospital
Madison, Wisconsin, United States
RECRUITINGRadiographic evidence of fracture healing
AP and lateral x-rays
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Pain relief
Visual Analog Scale (VAS) pain score at fracture site. 0-10 scale, lower score means less pain.
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
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