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 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.

Study Overview

• Status: Terminated
• Conditions: Fractures, Bone; Fractures, Closed; Fractures, Open; Fracture of Femur; Fracture of Tibia; Limb Fracture; Fracture Nonunion; Limb Deformity; Limb Defect; Limb Asymmetry
• Intervention / Treatment: Device: Fitbone Transport and Lengthening System

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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sanai Medical Center
    • Orange, California, United States, 92868
      • University California - Irvine
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University School of Medicine / Grady Memorial Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Gillette Children's Specialty Healthcare
  • New York
    • Buffalo, New York, United States, 14203
      • The Research Foundation for SUNY
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Nationwide Children's Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; 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.; Other Names: Fitbone Transport Nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 %).	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 %).	1 year post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness - Bone Healing	Radiographic evidence of healing of 3 out of 4 cortices	1 year and 2 years post-operative
Effectiveness - Consolidation Index	Time to achieve bone healing (days)/ achieved length (cm)	1 year and 2 years post-operative
Effectiveness - Distraction Index	Time of distraction (days)/ achieved length (cm)	1 year post-operative
Effectiveness - Nail Reliability	Ratio between the achieved length and the planned length	1 year post-operative
Effectiveness -Time to Transport and Lengthening	Time to achieve transport and lengthening	1 year post-operative
Effectiveness - Range of Motion	Loss of Range of Motion at full consolidation; degrees from baseline	1 year and 2 years post-operative
Safety -Nail Extraction	Nail extraction complications/failures	1 year post-operative
Effectiveness - Patient Reported Outcome Measures (PROMs)	Improvement in PROMS scores (Pain, Quality of Life) obtained per standard of care	1 year and 2 years post-operative
Effectiveness - Mobility Measures	Improvement in gait analysis	approximately 2 years post-operative
Safety - Adverse Events	Evaluation and classification of all adverse events including device-related, procedure-related and serious adverse events.	Index surgery through study completion; approximately 2 years post-operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint	The percentage of cases in which unplanned reoperations and/or revision surgery occurred.	1 year and 2 years post-operative

Collaborators and Investigators

• Sponsor: Orthofix Inc.
• Investigators: Study Director: Jay Erturan, MD, JD, Orthofix Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Actual): February 28, 2026
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Limb Lengthening; Limb Deformity Correction; Bone Transport
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Fractures, Ununited; Femoral Fractures; Fractures, Open; Tibial Fractures; Fractures, Closed
• Other Study ID Numbers: CIP-FBBT-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No