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

NCT06400732 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2026-04-02

No results posted yet for this study

Summary

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.

Conditions

  • Fractures, Bone
  • Fractures, Closed
  • Fractures, Open
  • Fracture of Femur
  • Fracture Nonunion
  • Fracture of Tibia
  • Limb Deformity
  • Limb Fracture
  • Limb Defect
  • Limb Asymmetry

Interventions

DEVICE

Fitbone Transport and Lengthening System

Implantation of the intramedullary Fitbone Transport Nail and subsequent bone segment transport and, optionally, lengthening.

Sponsors & Collaborators

  • Orthofix Inc.

    lead INDUSTRY

Principal Investigators

  • Jay Erturan, MD, JD · Orthofix Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06400732 on ClinicalTrials.gov