NCT06400732

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Orthofix Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Fitbone Transport and Lengthening System	Implantation of the intramedullary Fitbone Transport Nail and subsequent bone segment transport and, optionally, lengthening.

Timeline

• Start date: 2024-11-19
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2024-05-06
• Last updated: 2026-04-02

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study