Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 8:46 PM
Study NCT ID:
NCT06400732
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
Sponsor:
Orthofix Inc.
Organization:
Study Overview
Official Title:
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: