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โ† Trials
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BoneTape Feasibility Trial

RecruitingNAAges any - anyAllCohesys Inc.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Patients who meet all of the following criteria will be eligible for inclusion 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-up visits; * Able and willing to provide informed assent or consent. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study: * Present critically sized bone defects\*, as determined by the investigator; * Have a fracture of the orbital floor requiring operative intervention; * Are pregnant; * 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 baseline pre-operative assessment; * Are smokers; * 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.
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What it tests

  • BoneTape
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Where

1 site
Sunnybrook Health Sciences Centre
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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