This is an open-label, prospective, observational, post-market, uncontrolled, multi-center study intended to evaluate the safety and clinical performance of the FITBONE Transport and Lengthening Nail when used according to the manufacturer's Instructions for Use. The FITBONE Transport \& Lengthening Nail is a variant of the FITBONE TAA Nail, which has been commercially available in the US since 2017. The clinical performance and safety of the medical device have been assessed based on mechanical and biomechanical tests and clinical data obtained from scientific publications on equivalent products. This study intends to prospectively obtain clinical safety and performance data on the device, as used according to the manufacturer's Instructions for Use, in the real-world clinical setting. The data obtained from this study will also be used to provide additional clinical evidence to support product registrations, as required by various regulatory bodies outside the US. Eligible participants will have been selected by their physician to be treated with the FITBONE Transport and Lengthening System as part of treatment for their condition or injury. All procedures will be according to the physician's standard care practices. There are no study-specific procedures or requirements for participants in this study.
This is an open-label, prospective, observational, post-market, uncontrolled, multi-center study intended to evaluate the safety and clinical performance of the FITBONE Transport and Lengthening Nail when used according to the manufacturer's Instructions for Use. The FITBONE Transport \& Lengthening Nail is a variant of the FITBONE TAA Nail, which has been commercially available in the US since 2017. The clinical performance and safety of the medical device have been assessed based on mechanical and biomechanical tests and clinical data obtained from scientific publications on equivalent products. This study intends to prospectively obtain clinical safety and performance data on the device, as used according to the manufacturer's Instructions for Use, in the real-world clinical setting. The data obtained from this study will also be used to provide additional clinical evidence to support product registrations, as required by various regulatory bodies outside the US. Eligible participants will have been selected by their physician to be treated with the FITBONE Transport and Lengthening System as part of treatment for their condition or injury. All procedures will be according to the physician's standard care practices. There are no study-specific procedures or requirements for participants in this study.
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
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University of Arkansas Medical Sciences, Little Rock, Arkansas, United States, 72205
Cedars Sanai Medical Center, Los Angeles, California, United States, 90048
University California - Irvine, Orange, California, United States, 92868
Emory University School of Medicine / Grady Memorial Hospital, Atlanta, Georgia, United States, 30303
Indiana University School of Medicine, Indianapolis, Indiana, United States, 46202
Sinai Hospital of Baltimore, Baltimore, Maryland, United States, 21215
Gillette Children's Specialty Healthcare, Saint Paul, Minnesota, United States, 55101
The Research Foundation for SUNY, Buffalo, New York, United States, 14203
Nationwide Children's Hospital, Columbus, Ohio, United States, 43215
University of Virginia Health, Charlottesville, Virginia, United States, 22903
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Orthofix Inc.,
Jay Erturan, MD, JD, STUDY_DIRECTOR, Orthofix Inc.
2028-11