Stopped: Business decision
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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety - Percentage of unplanned reoperation and/or revision surgery.
Timeframe: 1 year post-operative
Performance - Percentage of achievement of planned lengthening. Length of the planned transport (and lengthening when applicable) vs the actual overall length of the segment at the time of nail extraction.
Timeframe: 1 year post-operative