BridgeMD
New treatment option for Zygomaticomaxillary Complex Fracture
Official title BoneTape Feasibility Trial
ClinicalTrials.gov ID: NCT06600854
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.