Zygomaticomaxillary Complex FractureNCT06600854
BoneTape Feasibility Trial
A study testing BoneTape in people with Zygomaticomaxillary Complex Fracture and Zygomatic Fractures, run by Cohesys Inc. at 1 site in Canada.
Trial 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) region. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Zygomaticomaxillary Complex Fracture, Zygomatic Fractures, Zygoma Fracture
- What is being tested?
- BoneTape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 5 May 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Meghan Ryan, +1 416-480-4285, meghan.ryan@sri.utoronto.ca
Jeffrey A Fialkov, MD, MSc., FRCSC
About this study
Official title: Clinical Feasibility of BoneTape: a Novel Approach for Zygomaticomaxillary Fracture Fixation
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. Traditional methods use metal plates and screws, which can be complicated to install, over-engineered for the area, and may lead to complications, requiring additional surgeries.
BoneTape is a new, resorbable (biodegradable) device that offers a simpler, potentially safer alternative. Unlike traditional metal hardware, BoneTape is a flexible, thin plate that can be easily cut to the required shape during surgery and applied directly to the bone using a special tool that anchors it without needing to drill or screw holes. This process significantly simplifies the surgical procedure, reduces the time needed for fixation, and avoids complications associated with drilling into healthy bone tissue.
Read more
Study Objectives:
Feasibility: Determine if BoneTape can be successfully used to stabilize midfacial fractures.
Effectiveness: Assess the ability of BoneTape to help bones heal properly without additional complications.
Safety: Monitor and evaluate any adverse events related to the use of BoneTape.
Study Design:
The study is designed as a single-arm, cohort study.
Participants will undergo baseline pre-operative assessments, including clinical exams, CT scans, and pain questionnaires. BoneTape will be applied during surgery, and post-operative assessments will take place within 24 hours. Follow-up visits will occur at 1 week, 6 weeks, 24 weeks, and 12 months to monitor the healing process, assess pain levels, and check for any adverse events.
Eligibility Criteria:
Inclusion:
Adults with a unilateral, non-comminuted (not broken into multiple pieces) zygomaticomaxillary fracture requiring surgery.
Must be skeletally mature, able and willing to attend follow-up visits, and provide informed consent.
Exclusion:
Patients with critically sized bone defects, fractures requiring orbital floor surgery, pregnancy, certain medical conditions impairing bone healing, or those unwilling or unable to follow the study procedures.
Study Duration:
The total study duration is expected to be 21-24 months, including the 12-month follow-up period for each participant.
Outcome Measures:
The primary outcomes include the feasibility of the procedure (successful use of BoneTape without additional hardware), early effectiveness (bone healing and stability at 6 and 24 weeks), and safety (rate and type of adverse events up to 24 weeks). Secondary outcomes will assess long-term safety and effectiveness at 12 months, patient-reported outcomes on pain, and physician feedback on device usability.
This study is a critical step in evaluating BoneTape as a potential alternative to current facial bone fixation methods, potentially improving surgical outcomes and patient quality of life by reducing the complexity of procedures and minimizing the need for additional surgeries.
- Being tested
- BoneTape
- Keywords
- Craniomaxillofacial, Zygomaticomaxillary, Fracture, Medical Device, Fracture Fixation, Zygomatic Fractures, Implant, BoneTape™
- Medical subject headings
- Zygomatic Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoneTapeDevice
BoneTape is a craniofacial fracture repair device intended for use in the fixation of non-load-bearing bones of the craniofacial and midfacial skeleton. It can be used in skeletally mature individuals but is not intended for use in the mandible and/or full load bearing procedures. It is composed of: 1) BoneTape implant ("device"), and 2) BoneTape applicator ("applicator").
| Study group | Role | What they receive |
|---|---|---|
| BoneTape | Experimental | Not described Receives: Device: BoneTape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Procedure success in target population.
Measured: Intervention
Early Efficacy
Clinical and radiographic bone union
Measured: Intervention to 24-weeks post-op
Early Safety
Rate of adverse events
Measured: Intervention to 24-weeks post-op
Secondary outcomes (3)
Safety and Efficacy
Rate of adverse events and clinical examination
Measured: Intervention to 12-months post-op
Pain
Pain scored using Numerical rating Scale
Measured: Baseline to 12 months post-op
Physician usability and feedback
Surgeon will complete a specific questionnaire to rate and provide feedback
Measured: Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 May 2025
- Primary completion5 Jan 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomaticomaxillary Complex FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cohesys Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600854
- Sponsor's protocol ID
- BT-CMF-001
- Status last verified
- Aug 2025
- First submitted
- 11 Sep 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of BoneTape: a Novel Approach for Zygomaticomaxillary Fracture Fixation
- ClinicalTrials.gov ID
- NCT06600854
- Acronym / sponsor ID
- BT-CMF-001
- Keywords
- Craniomaxillofacial, Zygomaticomaxillary, Fracture, Medical Device, Fracture Fixation, Zygomatic Fractures, Implant, BoneTape™
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cohesys Inc.Industry (pharma, biotech, devices)
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Traditional methods use metal plates and screws, which can be complicated to install, over-engineered for the area, and may lead to complications, requiring additional surgeries.
BoneTape is a new, resorbable (biodegradable) device that offers a simpler, potentially safer alternative. Unlike traditional metal hardware, BoneTape is a flexible, thin plate that can be easily cut to the required shape during surgery and applied directly to the bone using a special tool that anchors it without needing to drill or screw holes. This process significantly simplifies the surgical procedure, reduces the time needed for fixation, and avoids complications associated with drilling into healthy bone tissue.
Study Objectives:
Feasibility: Determine if BoneTape can be successfully used to stabilize midfacial fractures.
Effectiveness: Assess the ability of BoneTape to help bones heal properly without additional complications.
Safety: Monitor and evaluate any adverse events related to the use of BoneTape.
Study Design:
The study is designed as a single-arm, cohort study.
Participants will undergo baseline pre-operative assessments, including clinical exams, CT scans, and pain questionnaires. BoneTape will be applied during surgery, and post-operative assessments will take place within 24 hours. Follow-up visits will occur at 1 week, 6 weeks, 24 weeks, and 12 months to monitor the healing process, assess pain levels, and check for any adverse events.
Eligibility Criteria:
Inclusion:
Adults with a unilateral, non-comminuted (not broken into multiple pieces) zygomaticomaxillary fracture requiring surgery.
Must be skeletally mature, able and willing to attend follow-up visits, and provide informed consent.
Exclusion:
Patients with critically sized bone defects, fractures requiring orbital floor surgery, pregnancy, certain medical conditions impairing bone healing, or those unwilling or unable to follow the study procedures.
Study Duration:
The total study duration is expected to be 21-24 months, including the 12-month follow-up period for each participant.
Outcome Measures:
The primary outcomes include the feasibility of the procedure (successful use of BoneTape without additional hardware), early effectiveness (bone healing and stability at 6 and 24 weeks), and safety (rate and type of adverse events up to 24 weeks). Secondary outcomes will assess long-term safety and effectiveness at 12 months, patient-reported outcomes on pain, and physician feedback on device usability.
This study is a critical step in evaluating BoneTape as a potential alternative to current facial bone fixation methods, potentially improving surgical outcomes and patient quality of life by reducing the complexity of procedures and minimizing the need for additional surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BoneTape | Experimental | Device: BoneTape |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BoneTapeBoneTape is a craniofacial fracture repair device intended for use in the fixation of non-load-bearing bones of the craniofacial and midfacial skeleton. It can be used in skeletally mature individuals but is not intended for use in the mandible and/or full load bearing procedures. It is composed of: 1) BoneTape implant ("device"), and 2) BoneTape applicator ("applicator"). | Device | BoneTape |
Primary outcome
Feasibility
Time frame: Intervention
Procedure success in target population.
Early Efficacy
Time frame: Intervention to 24-weeks post-op
Clinical and radiographic bone union
Early Safety
Time frame: Intervention to 24-weeks post-op
Rate of adverse events
3 secondary outcomes
Safety and Efficacy
Time frame: Intervention to 12-months post-op
Pain
Time frame: Baseline to 12 months post-op
Physician usability and feedback
Time frame: Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Zygomaticomaxillary Complex Fracture
Enrolling by invitation
Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures
Zygomaticomaxillary Complex Fracture, Zygoma Fracture
Not yet recruiting
Accuracy of Virtual Surgical Planning Versus Traditional Technique in Zygomaticomaxillary Fracture Reduction
Facial Bone Fracture, Maxillofacial Injury
Enrolling by invitationObservational study
Multi-Institutional IMPACT Validation
Facial Injuries, Mandible Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BoneTape in people with Zygomaticomaxillary Complex Fracture and Zygomatic Fractures, run by Cohesys Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janaina F Bortolatto, DDS, PhD (1 437-344-3392, jbortolatto@cohesys.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.