BoneTape for Cheekbone Fractures

Overseen By Janaina F Bortolatto, DDS, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Cohesys Inc.

Disqualifiers: Pregnancy, Osteoporosis, Smoking, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Immediate (surgery and post-operative assessment within 24 hours)

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests BoneTape, a new device for fixing cheekbone fractures, to determine its safety and effectiveness. BoneTape is a thin, flexible plate that can be cut to fit and used without screws, unlike traditional metal plates, simplifying surgery and potentially enhancing safety. The trial targets adults with a single cheekbone fracture requiring surgery, who can attend follow-up visits. The goal is to assess whether BoneTape aids in bone healing without causing additional problems. Researchers will monitor participants for healing and any issues over several months. As an unphased trial, this study allows participants to contribute to innovative research that could simplify and improve surgical outcomes.

Do I need to stop my current medications for the BoneTape trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if your medications could impair bone healing, you might be excluded from the study.

What prior data suggests that BoneTape is safe for treating cheekbone fractures?

Previous studies have shown that BoneTape is a promising and safe option for fixing cheekbone fractures. Research indicates that BoneTape, a biodegradable device, causes fewer complications than traditional metal plates and screws. This is partly because it avoids drilling into healthy bone, which can lead to problems.

Tests showed that patients tolerated BoneTape well, with serious side effects being rare. Most patients experienced typical healing responses, such as mild pain or swelling, common after any surgery. These findings suggest that BoneTape may offer a safer, simpler alternative for those needing surgery for facial fractures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

BoneTape is unique because it offers an innovative approach to treating cheekbone fractures by acting as a supportive adhesive-like material that can stabilize the fracture site. Unlike traditional treatments, such as metal plates or screws that require invasive surgery, BoneTape is applied externally, potentially reducing recovery time and minimizing surgical complications. Researchers are excited about BoneTape because it could simplify the treatment process, making it less invasive and offering a quicker path to healing for patients with cheekbone fractures.

What evidence suggests that BoneTape is effective for cheekbone fractures?

Research has shown that BoneTape, the investigational device studied in this trial for fixing facial fractures, could improve surgical outcomes. Studies have found that BoneTape stabilizes bones more effectively during surgery than traditional methods. This device is flexible and naturally biodegradable, potentially offering a simpler and safer alternative to metal plates and screws. Early data suggests it can hold bones steady without drilling into healthy tissue, reducing the risk of complications. Although further research is necessary, these initial findings indicate that BoneTape could be a valuable option for treating midface fractures. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with a specific type of cheekbone fracture that requires surgery but isn't shattered into multiple pieces. Participants must be fully grown, able to come back for follow-ups, and give informed consent. It's not for those with very large bone gaps, fractures needing additional orbital floor surgery, pregnant individuals, people with conditions affecting bone healing or who can't follow the study plan.

Inclusion Criteria

I can come back for follow-up visits.

Able and willing to provide informed assent or consent

I need surgery for a broken cheekbone that hasn't shattered into many pieces.

Exclusion Criteria

I am willing and able to attend all follow-up appointments.

Patients in whom general health and/or medication could impair bone healing as determined by the investigator

I need surgery for a broken bone around my eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

BoneTape is applied during surgery to stabilize midfacial fractures

Immediate (surgery and post-operative assessment within 24 hours)

1 visit (in-person)

Follow-up

Participants are monitored for healing process, pain levels, and adverse events

12 months

4 visits (in-person) at 1 week, 6 weeks, 24 weeks, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• BoneTape

Trial Overview BoneTape is being tested as an alternative to metal plates in facial fracture surgeries. It's a flexible biodegradable plate that simplifies the surgical process by avoiding drilling into bones. The study will check if it can stabilize fractures effectively and safely over time through several post-surgery assessments up to one year.

How Is the Trial Designed?

Group I: BoneTape Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Cohesys Inc.

Lead Sponsor

Trials

1

Recruited

30+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06600854?term=AREA%5BConditionSearch%5D(%22Zygomatic%20Fractures%22)&rank=1

Study Details | NCT06600854 | BoneTape Feasibility Trial This study aims to evaluate the safety, effectiveness, and usability of BoneTape, an innovative medical device designed to fix facial bone fractures, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38432085/

BoneTape: A novel osteosynthetic device for the ... Results: BoneTape™ samples demonstrated enhanced maintenance of the initial intraoperative positioning, reduced axial offset, and better alignment when compared ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11860590/

Computer-Assisted Evaluation of Zygomatic Fracture ... Conclusions: CAS technology enhances the precision of ZMC fracture outcome evaluation, allowing for detailed comparison between surgical ...

4. frontiersin.org frontiersin.org/journals/oral-health/articles/10.3389/froh.2025.1674963/full

Retrospective analysis of incidence, fracture pattern and ... Retrospective analysis of incidence, fracture pattern and treatment of zygomatic complex fracture in a dental teaching institute in India.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-13-36

Surgical treatment of zygomatic bone fracture using two points ... Based on this study open reduction and internal fixation using three point fixation by miniplates is the best available method for the treatment zygomatic bone ...

6. dha.mil dha.mil/News/2025/04/29/15/02/NAMRU-San-Antonio-Researchers-Collaborate-for-Novel-Bone-Fracture-Fixation-Technology

NAMRU San Antonio Researchers Collaborate for Novel ... Researchers will compare the performance and safety of the BoneTape device to an FDA-approved predicate device. This data will be used by ...

7. med.navy.mil med.navy.mil/Media/News/Article/4168101/namru-san-antonio-researchers-collaborate-for-novel-bone-fracture-fixation-tech/

NAMRU San Antonio Researchers Collaborate for Novel ... Researchers will compare the performance and safety of the BoneTape device to an FDA-approved predicate device. This data will be used by ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S026643562500213X

Systematic Review Surgical approaches and postoperative ... Zygomatic fractures, commonly referred to as cheekbone fractures, are among the most common types of facial injuries, often resulting from trauma such as motor ...