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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-11-19 |
| Est. Completion | 2028-11 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06400732
The ClinicalTrials.gov registry entry for NCT06400732 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,943-participant average among 12 other Fractures, Bone trials with a reported enrollment target (98% lower). The listed sponsor is Orthofix, which has 14 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 8 distinct geographic areas - top geographies include 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.
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