Status:
RECRUITING
BoneTape Feasibility Trial
Lead Sponsor:
Cohesys Inc.
Conditions:
Zygomaticomaxillary Complex Fracture
Zygomatic Fractures
Eligibility:
All Genders
Phase:
NA
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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06600854
Start Date
May 5 2025
End Date
May 1 2027
Last Update
August 22 2025
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5