An observational study in Fractures, Bone, Fractures, Closed and Fractures, Open, sponsored by Orthofix Inc.. Terminated at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Orthofix Inc. · Observational
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.
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:
Safety Endpoint:
The percentage of cases in which unplanned reoperations and/or revision surgery occurred.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's enrollment of 1 is below the median of 130 across 239 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Orthofix Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants treated for a limb defect with the Fitbone Transport and Lengthening System
Device: Fitbone Transport and Lengthening System
Implantation of the intramedullary Fitbone Transport Nail and subsequent bone segment transport and, optionally, lengthening.
Also known as: Fitbone Transport Nail
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 %).
Time frame: 1 year post-operative
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 %).
Time frame: 1 year post-operative
Effectiveness - Bone Healing
Radiographic evidence of healing of 3 out of 4 cortices
Time frame: 1 year and 2 years post-operative
Effectiveness - Consolidation Index
Time to achieve bone healing (days)/ achieved length (cm)
Time frame: 1 year and 2 years post-operative
Effectiveness - Distraction Index
Time of distraction (days)/ achieved length (cm)
Time frame: 1 year post-operative
Effectiveness - Nail Reliability
Ratio between the achieved length and the planned length
Time frame: 1 year post-operative
Effectiveness -Time to Transport and Lengthening
Time to achieve transport and lengthening
Time frame: 1 year post-operative
Effectiveness - Range of Motion
Loss of Range of Motion at full consolidation; degrees from baseline
Time frame: 1 year and 2 years post-operative
Safety -Nail Extraction
Nail extraction complications/failures
Time frame: 1 year post-operative
Effectiveness - Patient Reported Outcome Measures (PROMs)
Improvement in PROMS scores (Pain, Quality of Life) obtained per standard of care
Time frame: 1 year and 2 years post-operative
Effectiveness - Mobility Measures
Improvement in gait analysis
Time frame: approximately 2 years post-operative
Safety - Adverse Events
Evaluation and classification of all adverse events including device-related, procedure-related and serious adverse events.
Time frame: Index surgery through study completion; approximately 2 years post-operative
Primary Safety Endpoint
The percentage of cases in which unplanned reoperations and/or revision surgery occurred.
Time frame: 1 year and 2 years post-operative
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2024 to primary completion in Feb 2026, 15 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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