Testing BoneTape for zygomaticomaxillary complex fracture
Official title: BoneTape Feasibility Trial
Clinical Feasibility of BoneTape: a Novel Approach for Zygomaticomaxillary Fracture Fixation
- 1 group
- One site, in Toronto
- Recruiting
Interventions
- Medical device
BoneTape
BoneTape is a craniofacial fracture repair device intended for use in the fixation of non-load-bearing bones of the craniofacial and midfacial skeleton. It can be used in skeletally mature individuals but is not intended for use in the mandible and/or full load bearing procedures. It is composed of: 1) BoneTape implant ("device"), and 2) BoneTape applicator ("applicator").
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients who meet all of the following criteria will be eligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → in the study:
- +Have a non-comminuted unilateral unstable zygomatico-maxillary fracture at one or more sites requiring operative intervention;
- +Are skeletally mature;
- +Able and willing to return for follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → visits;
- +Able and willing to provide informed assent or consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
Exclusion
- −Patients who meet any of the following criteria will be excluded from the study:
- −Present critically sized bone defects\*, as determined by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →;
- −Have a fracture of the orbital floor requiring operative intervention;
- −Are not willing or able to participate in follow-ups;
- −In whom the general health and/or medication could impair bone healing, as determined by the investigator;
- −Are pre-diagnosed with osteoporosis or are diagnosed by the investigator during baselineBaselineYour starting measurements, taken before treatment begins.Read more → pre-operative assessment;
- −Have a pacemaker;
- −Have active or latent infection.
- −A critically sized bone defect refers to a bone injury or loss that is of sufficient size such that it exceeds the natural regenerative capacity of the bone, rendering spontaneous healing unlikely over the patient's lifetime. The determination of a \'critical size\' is case-dependent and requires clinical judgment, taking into account factors such as the specific bone affected, its location, the blood supply to the area, the presence of surrounding soft tissues, and the patient\'s overall health status.
- −Are pregnant;
- −Are smokers;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives BoneTape.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 30 people.
The study is currently expected to finish around May 2027.
The main measurement is taken over: Intervention.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility — measured over Intervention.
Early Efficacy — measured over Intervention to 24-weeks post-op.
Early Safety — measured over Intervention to 24-weeks post-op.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06600854 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BoneTapeDevice
BoneTape is a craniofacial fracture repair device intended for use in the fixation of non-load-bearing bones of the craniofacial and midfacial skeleton. It can be used in skeletally mature individuals but is not intended for use in the mandible and/or full load bearing procedures. It is composed of: 1) BoneTape implant ("device"), and 2) BoneTape applicator ("applicator").
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Intervention.
The study as a whole is currently expected to finish around 2027-05-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 30 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.