BoneTape for fixing midface (zygomatic) fractures

Clinical Feasibility of BoneTape: a Novel Approach for Zygomaticomaxillary Fracture Fixation

This will test BoneTape, a biodegradable flexible plate that anchors without screws, to repair zygomatic (midface) fractures in adults who need surgical fixation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sex: All
• Sponsor: Cohesys Inc. (Industry-sponsored)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06600854 on ClinicalTrials.gov

What this trial studies

This feasibility study uses a resorbable, thin, flexible device called BoneTape that can be cut to shape and anchored to the zygomaticomaxillary region without drills or screws. Eligible skeletally mature adults with non-comminuted unilateral unstable zygomaticomaxillary fractures will receive BoneTape fixation during surgery and attend scheduled follow-up visits to monitor healing, device handling, and any complications. Outcomes will focus on device safety, effectiveness in stabilizing the fracture, and surgeon-reported usability and procedure time. The device is intended to simplify fixation compared with traditional metal plates and reduce the need for future hardware removal.

Who should consider this trial

Good fit: Adults who are skeletally mature with a non-comminuted unilateral unstable zygomaticomaxillary fracture requiring operative fixation and who can attend follow-up visits are ideal candidates.

Not a fit: Patients with comminuted or critically sized bone defects, fractures needing orbital floor surgery, active/latent infection, osteoporosis, smokers, pacemakers, pregnancy, or any condition that impairs bone healing are unlikely to benefit from this device.

Why it matters

Potential benefit: If successful, BoneTape could shorten operative time, lower hardware-related complications, and eliminate the need for a second surgery to remove metal plates or screws.

How similar studies have performed: While resorbable fixation systems have been used successfully in facial fracture care, the screwless, tape-like anchoring approach of BoneTape is novel and currently has limited clinical data.

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.

Where this trial is running

Toronto, Ontario

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Janaina F Bortolatto, DDS, PhD

Conditions Zygomaticomaxillary Complex Fracture; Zygomatic Fractures; Zygoma Fracture; Craniomaxillofacial; Zygomaticomaxillary; Fracture; Medical Device; Fracture Fixation