Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System

Stopped early

Conditions studied: Fractures, Bone, Fractures, Closed, Fractures, Open, Fracture of Femur, Fracture Nonunion, Fracture of Tibia, Limb Deformity, Limb Fracture, Limb Defect, Limb Asymmetry

In brief

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.

Key facts

Study ID

NCT06400732

Run by

Orthofix Inc.

People needed

1

Starts

2024-11-19

Expected to finish

2026-02-28

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years old
• Expressed willingness to participate in the study by signing and dating the informed consent form
• Has a segmental bone defect, or limb length defect of at least 2 mm up to ≤ 120 mm, considered suitable for correction with an intramedullary lengthening nail, as confirmed by radiographs.

You may not qualify if…

• Conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease, or evidence of inadequate vascularity
• Poor bone quality that would prevent adequate fixation of the device
• Compromised capacity for healing
• Metal allergies and sensitivities
• Patients in which the implant would cross open, healthy epiphyseal growth plates
• Insufficient intramedullary space which would lead to cortical weakening or vascular damage during implantation
• Body weight of > 100 kg
• No free access for proximal insertion of the intramedullary transport and lengthening nail (e.g., coxa valga)
• No reliable exclusion of bone infection
• Expected non-compliance, mentally ill patient or patient with clouded consciousness
• Pregnancy
• Pre-existing nerve palsies
• Bone defect larger than 120 mm
• Gustilo Open Fracture Classification Grade IIIB or IIIC

Where it is running

• Cedars Sanai Medical Center — Los Angeles, California, United States
• University California - Irvine — Orange, California, United States
• Emory University School of Medicine / Grady Memorial Hospital — Atlanta, Georgia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States
• The Research Foundation for SUNY — Buffalo, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• University of Virginia Health — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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