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NCT06400732 · ClinicalTrials.gov registry record

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

A clinical trial of Fractures, Bone and Fractures, Open, sponsored by Orthofix.

Active
Registry status
30
Enrollment target
9
Study locations

NCT06400732: Active study of Fractures, Bone and Fractures, Open, sponsored by Orthofix.

NCT06400732 is a study of Fractures, Bone and Fractures, Open that is active but no longer recruiting, run by Orthofix. The registered enrollment target is 30 participants, below the 1,943-participant average among 12 other Fractures, Bone trials with a reported enrollment target (98% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06400732, a study of Fractures, Bone and Fractures, Open, is active but no longer recruiting, sponsored by Orthofix.

ACTIVE NOT RECRUITING
Registry status
30 participants
Enrollment target
9
Study locations

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.

Primary Outcome

Instances of re-operation and/or revision as categorized as "planned" or "unplanned" by the surgeon. Specifically, adverse events consisting of re-operation/revision surgery deemed to be related to the device or procedure will be tabulated and the incidence will be determined by dividing this by the total number of patients treated (expressed as %).

Conditions Studied

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

Interventions

  • DEVICE Fitbone Transport and Lengthening System

Study Locations (9)

California

  • Cedars Sanai Medical Center - Los Angeles
  • University California - Irvine - Orange

Georgia

  • Emory University School of Medicine / Grady Memorial Hospital - Atlanta

Indiana

  • Indiana University School of Medicine - Indianapolis

Maryland

  • Sinai Hospital of Baltimore - Baltimore

Minnesota

  • Gillette Children's Specialty Healthcare - Saint Paul

New York

  • The Research Foundation for SUNY - Buffalo

Ohio

  • Nationwide Children's Hospital - Columbus

Virginia

  • University of Virginia Health - Charlottesville

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-11-19
Est. Completion 2028-11
Orthofix

14 total trials

What the registry record for NCT06400732 still lists

NCT06400732 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,943-participant average among 12 other Fractures, Bone trials with a reported enrollment target (98% lower).

The record links to 10 conditions, with Fractures, Bone appearing as the primary indexed condition, and to 1 intervention - of which Fitbone Transport and Lengthening System is the first listed.

NCT06400732 lists 9 locations in 8 states (California, Georgia, Indiana).

Frequently Asked Questions

What is clinical trial NCT06400732 about?

NCT06400732 is a clinical study titled "Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System". 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...

What is the current status of trial NCT06400732?

This trial is currently active not recruiting. The enrollment target is 30 participants. The study started on 2024-11-19. Estimated completion is 2028-11.

What conditions does trial NCT06400732 study?

This clinical trial studies the following conditions: Fractures, Bone, Fractures, Open, Fractures, Closed, Fracture of Tibia, Fracture of Femur.

What interventions are being tested in trial NCT06400732?

The interventions under investigation include: Fitbone Transport and Lengthening System (DEVICE).

Who is sponsoring clinical trial NCT06400732?

This trial is sponsored by Orthofix, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06400732 being conducted?

This trial has 9 study locations across California, Georgia, Indiana, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Fractures, Bone

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06400732's enrollment target sits among peer trials

30 11th of 12 higher than 2 of 12 other Fractures, Bone trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Fractures, Bone trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06400732, the US trial registry maintained by the National Library of Medicine. NCT06400732 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.