BoneTape Feasibility Trial

Launched by COHESYS INC. · Sep 13, 2024

Keywords

ClinConnect Summary

The BoneTape Feasibility Trial is testing a new device called BoneTape, which is designed to help fix facial bone fractures in the midface area, specifically the zygomaticomaxillary region. These fractures often happen due to accidents or falls and typically require surgery to ensure the bones heal correctly. Unlike traditional methods that use metal plates and screws, BoneTape is a flexible, biodegradable material that can be easily shaped during surgery and applied without drilling into the bone. This could make surgeries simpler, quicker, and potentially safer for patients.

To participate in this study, you need to be an adult with a specific type of facial fracture that isn’t broken into multiple pieces and requires surgery. You should be able to attend follow-up visits and give permission to be part of the study. If you join, you will have some tests before surgery and be monitored after the procedure to see how well BoneTape works and if it causes any side effects. The trial is important because it could lead to better treatment options for facial fractures, improving recovery and reducing the need for further surgeries.

Gender

ALL

Eligibility criteria

• 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.