Fractures, Bone Clinical Trial
Official title:
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
The goal of this observational study is to examine and confirm the clinical performance of the Fitbone Transport and Lengthening System in adult patients (21 years and older) who require lower-limb lengthening, fracture fixation and/or treatment for previous non-healing fracture. The main questions it aims to answer are: 1. Are their any unanticipated safety issues with the product when used in a real-world setting? 2. Does the product provide the anticipated clinical benefit when used in a real-world setting? 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 prospective, observational clinical study is aimed at actively collecting clinical data related to the use of the Fitbone Transport and Lengthening System in a representative number of users and patients, observed in the short (<1yr) and medium (approximately 2 years) term after implantation of the device. The first co-primary objective of the Clinical Study is to evaluate the safety of the Fitbone Transport Nail, which will be measured in terms of percentage of participants with unplanned reoperation and/or revision surgery. The second co-primary objective of the clinical study is to evaluate the clinical performance of the Fitbone Transport and Lengthening System as measured by percentage of participants with achievement of planned lengthening. ;
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