AzTrials
AzTrials

Fractures, BoneNCT06400732

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

An observational study of Fractures, Bone and Fractures, Closed, run by Orthofix Inc. at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fitbone Transport and Lengthening System
Type of treatment
Medical device
How many people
1 participants
Where
9 sitesUnited States
Study dates
19 Nov 2024to 28 Feb 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • ≥ 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Emory University School of Medicine / Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • The Research Foundation for SUNY

    Buffalo, New York, 14203

  • University of Virginia Health

    Charlottesville, Virginia, 22903

  • Nationwide Children's Hospital

    Columbus, Ohio, 43215

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Cedars Sanai Medical Center

    Los Angeles, California, 90048

  • University California - Irvine

    Orange, California, 92868

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota, 55101

Other trials in United States

About this study

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.

Read the detailed description

This prospective, observational clinical study intends to actively collect clinical data related to the use of the FITBONE Transport and Lengthening System in a representative number of users and patients, observed in the short (<1yr) and medium (approximately 1 and 2 years) term after implantation of the device.

Co-Primary Endpoints:

Primary Safety Endpoint: Percentage of unplanned reoperation and/or revision surgery. Instances of re-operation and/or revision as categorized as "planned" or "unplanned" by the surgeon.

Primary Performance Endpoint: Percentage of achievement of planned length. Length of the planned transport (and lengthening when applicable) vs the actual overall length of the segment at the time of nail extraction.

Secondary Endpoints:

  • Bone Healing: Radiographic evidence of healing of 3 out of 4 cortices
  • Consolidation Index: Time to achieve bone healing (days)/ achieved length (cm)
  • Distraction Index: Time of distraction (days)/ achieved length (cm)
  • Nail Reliability: Ratio between the number of successfully completed lengthening treatments and the number of implanted lengthening devices
  • Nail Accuracy: Ratio between the achieved length and the planned length
  • Time to achieve transport and lengthening
  • Loss of Range of Motion at full consolidation: degrees from baseline
  • Nail Extraction complications/failures
  • Patient-reported outcome measures
  • Mobility measures
  • Adverse events

Safety Endpoint:

The percentage of cases in which unplanned reoperations and/or revision surgery occurred.

Being tested
Fitbone Transport and Lengthening System
Keywords
Limb Lengthening, Limb Deformity Correction, Bone Transport
Medical subject headings
Fractures, Bone, Fractures, Closed, Fractures, Open, Femoral Fractures, Fractures, Ununited, Tibial Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fitbone Transport and Lengthening SystemDevice

    Also called Fitbone Transport Nail

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

Study groups in NCT06400732
Study groupRoleWhat they receive
Treatment GroupParticipants treated for a limb defect with the Fitbone Transport and Lengthening System
Receives: Device: Fitbone Transport and Lengthening System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety - Percentage of unplanned reoperation and/or revision surgery.

    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 %).

    Measured: 1 year post-operative

  2. Performance - Percentage of achievement of planned lengthening. Length of the planned transport (and lengthening when applicable) vs the actual overall length of the segment at the time of nail extraction.

    Incidence of participants in which successful attainment of target lengthening/distraction was obtained. Specifically, the outcome measure will be based on the difference between the physician's pre-specified target length/distraction to be obtained and the actual lengthening/distraction obtained following treatment. The physician will make a determination if this difference is acceptable for each subject. The incidence of successful lengthening will be determined by the number of clinical acceptable results divided by the total number of patients treated (expressed as %).

    Measured: 1 year post-operative

Secondary outcomes (10)

  1. Effectiveness - Bone Healing

    Radiographic evidence of healing of 3 out of 4 cortices

    Measured: 1 year and 2 years post-operative

  2. Effectiveness - Consolidation Index

    Time to achieve bone healing (days)/ achieved length (cm)

    Measured: 1 year and 2 years post-operative

  3. Effectiveness - Distraction Index

    Time of distraction (days)/ achieved length (cm)

    Measured: 1 year post-operative

  4. Effectiveness - Nail Reliability

    Ratio between the achieved length and the planned length

    Measured: 1 year post-operative

  5. Effectiveness -Time to Transport and Lengthening

    Time to achieve transport and lengthening

    Measured: 1 year post-operative

  6. Effectiveness - Range of Motion

    Loss of Range of Motion at full consolidation; degrees from baseline

    Measured: 1 year and 2 years post-operative

  7. Safety -Nail Extraction

    Nail extraction complications/failures

    Measured: 1 year post-operative

  8. Effectiveness - Patient Reported Outcome Measures (PROMs)

    Improvement in PROMS scores (Pain, Quality of Life) obtained per standard of care

    Measured: 1 year and 2 years post-operative

  9. Effectiveness - Mobility Measures

    Improvement in gait analysis

    Measured: approximately 2 years post-operative

  10. Safety - Adverse Events

    Evaluation and classification of all adverse events including device-related, procedure-related and serious adverse events.

    Measured: Index surgery through study completion; approximately 2 years post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start19 Nov 2024
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Why it stopped: Business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06400732
Sponsor's protocol ID
CIP-FBBT-23
Status last verified
Mar 2026
First submitted
29 Apr 2024
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fractures, Bone and Fractures, Closed, run by Orthofix Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - Percentage of unplanned reoperation and/or revision surgery. (time frame: 1 year post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06400732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in