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Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone in Foot and Ankle Surgery
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
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
Start Date
August 1, 2020
Primary Completion Date
May 10, 2024
Completion Date
May 10, 2024
Last Updated
May 13, 2024
200
ACTUAL participants
NanoBone Bone Graft Substitute
OTHER
Lead Sponsor
Artoss Inc.
NCT07072286
NCT06888934
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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