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

Fractures, Bone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06400732
• Other study ID #: CIP-FBBT-23
• Status: Not yet recruiting
• Start date: May 20, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Orthofix Inc.
• Contact: Clinical Program Manager, US Orthopedics
• Phone: 765-337-8454
• Email: billbourdeau[@]orthofix.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to examine and confirm the clinical performance of the Fitbone Transport and Lengthening System in adult patients (21 years and older) who require lower-limb lengthening, fracture fixation and/or treatment for previous non-healing fracture. The main questions it aims to answer are:

1. Are their any unanticipated safety issues with the product when used in a real-world setting?

2. Does the product provide the anticipated clinical benefit when used in a real-world setting?

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.

Description:

This prospective, observational clinical study is aimed at actively collecting 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 2 years) term after implantation of the device.

The first co-primary objective of the Clinical Study is to evaluate the safety of the Fitbone Transport Nail, which will be measured in terms of percentage of participants with unplanned reoperation and/or revision surgery.

The second co-primary objective of the clinical study is to evaluate the clinical performance of the Fitbone Transport and Lengthening System as measured by percentage of participants with achievement of planned lengthening.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• he/she has expressed his/her willingness, to participate in the Clinical Trial by signing and dating the informed consent (as required by IRB)

• they have a limb length defect up to 8cm (without utilizing "rewind and go" option) or longer considered as suitable for correction with an intramedullary lengthening nail

Exclusion Criteria:

1. Patients with conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity

2. Patients with poor bone quality that would prevent adequate fixation of the device

3. Patients with compromised capacity for healing

4. Patients with 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 an implantation

7. Patients with a 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. Patients with pre-existing nerve palsies

13. Patients with bone defects larger than 120 mm

14. Patients with Gustilo open fracture Classification Grade IIIB or IIIC fractures

as it could result in a treatment failure in the intended population.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Femoral Fractures
• Fracture Nonunion
• Fracture of Femur
• Fractures, Bone
• Fractures, Closed
• Fractures, Open
• Fractures, Ununited
• Limb Defect
• Limb Deformity
• Limb Fracture
• Tibial Fractures

Intervention

Device:
• Fitbone Transport and Lengthening System
Implantation of the intramedullary Fitbone Transport Nail and subsequent bone segment transport and, optionally, lengthening.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Orthofix Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Device/procedure-related adverse events requiring re-operation or surgical revision.	Incidence of participants requiring unplanned re-operation or revision surgery. 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
Primary	Performance - Final achieved lengthening/distraction (mm) as compared to pre-treatment target.	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