Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-29
Brief Title:
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
Sponsor:
Orthofix Inc
Organization:
Orthofix Inc
Study Overview
Official Title:
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
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 andor 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 physicians standard care practices There are no study-specific procedures or requirements for participants in this study
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 physicians standard care practices There are no study-specific procedures or requirements for participants in this study
Detailed 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
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?:
None