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

NCT06400732 | Terminated FDA Device

• 1 other identifier: CIP-FBBT-23
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 9

Brief 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

Fractures, Bone; Fractures, Closed; Fractures, Open; Fracture of Femur; Fracture Nonunion; Fracture of Tibia; Limb Deformity; Limb Fracture; Limb Defect; Limb Asymmetry

Keywords

Limb Lengthening; Limb Deformity Correction; Bone Transport

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Effectiveness - Bone Healing

  1 year and 2 years post-operative

• Effectiveness - Consolidation Index

  1 year and 2 years post-operative

• Effectiveness - Distraction Index

  1 year post-operative

• Effectiveness - Nail Reliability

  1 year post-operative

• Effectiveness -Time to Transport and Lengthening

  1 year post-operative

Other Outcomes (1)

• Primary Safety Endpoint

  1 year and 2 years post-operative

Study Arms (1)

Treatment Group

Participants treated for a limb defect with the Fitbone Transport and Lengthening System

Device: Fitbone Transport and Lengthening System

Interventions

Fitbone Transport and Lengthening System DEVICE

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

Also known as: Fitbone Transport Nail

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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
• Body weight of \> 100 kg
• No free access for proximal insertion of the intramedullary transport and lengthening nail (e.g., coxa valga)
• 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

Sponsors & Collaborators

• Orthofix Inc.: lead

Study Sites (9)

Cedars Sanai Medical Center

Los Angeles, California, 90048, United States

Location

University California - Irvine

Orange, California, 92868, United States

Location

Emory University School of Medicine / Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

The Research Foundation for SUNY

Buffalo, New York, 14203, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

University of Virginia Health

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Fractures, Closed; Fractures, Open; Femoral Fractures; Fractures, Ununited; Tibial Fractures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Study Officials

• Jay Erturan, MD, JD

  Orthofix Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 6, 2024
• Study Start: November 19, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)