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Bone-Lengthening nail study ends early after just one patient

NCT ID NCT06400732

Knowledge-focused Sponsor: Orthofix Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the safety and performance of the Fitbone Transport and Lengthening Nail, a device implanted in the bone to help repair large bone gaps or correct leg length differences. Only one person took part before the study was stopped early, so the results are very limited. The goal was to see how well the device works in real-world use and to support regulatory approvals outside the U.S.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fitbone Transport and Lengthening Nail (implantable device)
What this could lead to
If successful, this could confirm the device's safety and performance for treating bone defects and limb length differences.
What could go wrong
The study was terminated with only 1 participant, so results are very limited and may not apply to others. No conclusions can be drawn.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1 person

The number who actually took part.

Started

Nov 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients who are indicated, as described in the Instructions for Use, for treatment with the Fitbone Transport and Lengthening System for correction of limb deformity.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥ 18 years old 2. Expressed willingness to participate in the study by signing and dating the informed consent form 3. 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. Exclusion Criteria: 1. Conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease, or evidence of inadequate vascularity 2. Poor bone quality that would prevent adequate fixation of the device 3. Compromised capacity for healing 4. Metal allergies and sensitivities 5. Patients in which the implant would cross open, healthy epiphyseal growth plates 6. Insufficient intramedullary space which would lead to cortical weakening or vascular damage during implantation 7. Body weight of \> 100 kg 8. No free access for proximal insertion of the intramedullary transport and lengthening nail (e.g., coxa valga) 9. No reliable exclusion of bone infection 10. Expected non-compliance, mentally ill patient or patient with clouded consciousness 11. Pregnancy 12. Pre-existing nerve palsies 13. Bone defect larger than 120 mm 14. Gustilo Open Fracture Classification Grade IIIB or IIIC

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Conditions

The condition(s) this trial relates to.

bone fracture Femoral Fractures Fractures, Closed Fractures, Open Fractures, Ununited tibia fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fracture nonunion Fracture of femur Fracture of tibia Fractures, bone Fractures, closed Fractures, open Limb asymmetry Limb defect Limb deformity Limb fracture

Contacts and locations

Locations

  • Cedars Sanai Medical Center

    Los Angeles, California, 90048, United States

  • Emory University School of Medicine / Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota, 55101, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43215, United States

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215, United States

  • The Research Foundation for SUNY

    Buffalo, New York, 14203, United States

  • University California - Irvine

    Orange, California, 92868, United States

  • University of Virginia Health

    Charlottesville, Virginia, 22903, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.