Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600854
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
BoneTape Feasibility Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Feasibility of BoneTape a Novel Approach for Zygomaticomaxillary Fracture Fixation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the safety effectiveness and usability of BoneTape an innovative medical device designed to fix facial bone fractures specifically in the zygomaticomaxillary midface region Zygomaticomaxillary fractures often caused by trauma like car accidents or falls require surgery to align and stabilize the bones for proper healing Traditional methods use metal plates and screws which can be complicated to install over-engineered for the area and may lead to complications requiring additional surgeries
BoneTape is a new resorbable biodegradable device that offers a simpler potentially safer alternative Unlike traditional metal hardware BoneTape is a flexible thin plate that can be easily cut to the required shape during surgery and applied directly to the bone using a special tool that anchors it without needing to drill or screw holes This process significantly simplifies the surgical procedure reduces the time needed for fixation and avoids complications associated with drilling into healthy bone tissue
Study Objectives
Feasibility Determine if BoneTape can be successfully used to stabilize midfacial fractures
Effectiveness Assess the ability of BoneTape to help bones heal properly without additional complications
Safety Monitor and evaluate any adverse events related to the use of BoneTape
Study Design
The study is designed as a single-arm cohort study
Participants will undergo baseline pre-operative assessments including clinical exams CT scans and pain questionnaires BoneTape will be applied during surgery and post-operative assessments will take place within 24 hours Follow-up visits will occur at 1 week 6 weeks 24 weeks and 12 months to monitor the healing process assess pain levels and check for any adverse events
Eligibility Criteria
Inclusion
Adults with a unilateral non-comminuted not broken into multiple pieces zygomaticomaxillary fracture requiring surgery
Must be skeletally mature able and willing to attend follow-up visits and provide informed consent
Exclusion
Patients with critically sized bone defects fractures requiring orbital floor surgery pregnancy certain medical conditions impairing bone healing or those unwilling or unable to follow the study procedures
Study Duration
The total study duration is expected to be 21-24 months including the 12-month follow-up period for each participant
Outcome Measures
The primary outcomes include the feasibility of the procedure successful use of BoneTape without additional hardware early effectiveness bone healing and stability at 6 and 24 weeks and safety rate and type of adverse events up to 24 weeks Secondary outcomes will assess long-term safety and effectiveness at 12 months patient-reported outcomes on pain and physician feedback on device usability
This study is a critical step in evaluating BoneTape as a potential alternative to current facial bone fixation methods potentially improving surgical outcomes and patient quality of life by reducing the complexity of procedures and minimizing the need for additional surgeries
BoneTape is a new resorbable biodegradable device that offers a simpler potentially safer alternative Unlike traditional metal hardware BoneTape is a flexible thin plate that can be easily cut to the required shape during surgery and applied directly to the bone using a special tool that anchors it without needing to drill or screw holes This process significantly simplifies the surgical procedure reduces the time needed for fixation and avoids complications associated with drilling into healthy bone tissue
Study Objectives
Feasibility Determine if BoneTape can be successfully used to stabilize midfacial fractures
Effectiveness Assess the ability of BoneTape to help bones heal properly without additional complications
Safety Monitor and evaluate any adverse events related to the use of BoneTape
Study Design
The study is designed as a single-arm cohort study
Participants will undergo baseline pre-operative assessments including clinical exams CT scans and pain questionnaires BoneTape will be applied during surgery and post-operative assessments will take place within 24 hours Follow-up visits will occur at 1 week 6 weeks 24 weeks and 12 months to monitor the healing process assess pain levels and check for any adverse events
Eligibility Criteria
Inclusion
Adults with a unilateral non-comminuted not broken into multiple pieces zygomaticomaxillary fracture requiring surgery
Must be skeletally mature able and willing to attend follow-up visits and provide informed consent
Exclusion
Patients with critically sized bone defects fractures requiring orbital floor surgery pregnancy certain medical conditions impairing bone healing or those unwilling or unable to follow the study procedures
Study Duration
The total study duration is expected to be 21-24 months including the 12-month follow-up period for each participant
Outcome Measures
The primary outcomes include the feasibility of the procedure successful use of BoneTape without additional hardware early effectiveness bone healing and stability at 6 and 24 weeks and safety rate and type of adverse events up to 24 weeks Secondary outcomes will assess long-term safety and effectiveness at 12 months patient-reported outcomes on pain and physician feedback on device usability
This study is a critical step in evaluating BoneTape as a potential alternative to current facial bone fixation methods potentially improving surgical outcomes and patient quality of life by reducing the complexity of procedures and minimizing the need for additional surgeries
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None