Zygomatic FracturesUMFNCT07245719
Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up
An observational study of Zygomatic Fractures and Orbital Fractures, run by Stryker Craniomaxillofacial at 1 site in United States.
Trial summary
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Zygomatic Fractures, Orbital Fractures, Maxilla Fractures
- What is being tested?
- Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2025to 27 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Eligible patients will be identified as having had a surgical procedure involving the Subject Device.
Who may be able to join
- Skeletally mature patients at the time of surgery.
- Patients who underwent a craniomaxillofacial procedure using implants of the Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System as per routine clinical practice.
- Patients for whom data on the primary outcome variable is available.
- Patients with data available from follow-up visits.
Who cannot join
- Patients with active infections at the time of surgery.
- Patients with known metal allergies and/or foreign body sensitivity at the time of surgery.
- Subjects with non-reducible and unstable fractures (except reconstruction plates) at the time of surgery that were treated with the subject devices.
- Patients who underwent secondary reconstructions with non-secondary reconstruction plates
- Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medicine Oral and Maxillofacial Surgery 525 East 68th Street, F-2132
New York, New York, 10065
About this study
Official title: Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up to Confirm Safety, Performance and Effectiveness of The Universal CMF System
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.
Read the detailed description
This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of the Stryker Universal System when used in a clinical setting. This study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. Based on a non-inferiority study power calculation a minimum of 120 patients will be enrolled in the study. Additional patients may be enrolled up to 150 subjects depending on site enrolment rate and patient availability. Up to 2 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.
- Being tested
- Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System
- Medical subject headings
- Zygomatic Fractures, Orbital Fractures, Maxillary Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF SystemDevice
The Universal CMF System is a plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction.
Depending on the selected module, the design of the devices is more suitable for specific indications within the broad indication of CMF fractures and CMF reconstructive surgeries.
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery
Assessed by reviewing adverse events in patient medical charts at time point after surgery. Used to document whether an unplanned revision surgery was required or not for patients.
Measured: Data collected at a single time point per patient in the course of 12 months.
Secondary outcomes (7)
Intraoperative complications
Determined by intraoperative adverse events reported from patient medical charts.
Measured: Data collected at a single time point per patient in the course of 12 months.
Postoperative complications
Determined by post operative adverse events reported from patient medical charts.
Measured: Data collected at time points per patient in the course of 12 months.
Any known adverse events potentially related to the primary outcome objective and/or device
Determined by adverse events reported from patient medical charts.
Measured: Data collected at time points per patient in the course of 12 months.
Implant failure
Determined by adverse events reported from patient medical charts.
Measured: Data collected at time points point per patient in the course of 12 months.
Operating room (OR) time
Time patients are operated (dd:hh)
Measured: Data collected at a single time point per patient in the course of 12 months.
Hospitalization time
Time the patient was hospitalized post procedure (ICU and normal ward; dd:hh)
Measured: Data collected at a single time point per patient in the course of 12 months.
Post-operative bone consolidation
Clinical observation of post-op bone consolidation (medical charts) Timing of post-op observation of bone consolidation (yymmdd) Availability of post op imaging to determine bone consolidation Timing of post-op imaging (number of scans, yymmdd)
Measured: Data collected at time points point per patient in the course of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start28 Mar 2025
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomatic FracturesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Craniomaxillofacial
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245719
- Sponsor's protocol ID
- Universal CMF System _2023_01
- Acronym
- UMF
- Status last verified
- Apr 2026
- First submitted
- 7 Aug 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up to Confirm Safety, Performance and Effectiveness of The Universal CMF System
- ClinicalTrials.gov ID
- NCT07245719
- Acronym / sponsor ID
- UMF / Universal CMF System _2023_01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Stryker CraniomaxillofacialIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 24 Nov 2025 (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.
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.
Detailed description
This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of the Stryker Universal System when used in a clinical setting. This study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. Based on a non-inferiority study power calculation a minimum of 120 patients will be enrolled in the study. Additional patients may be enrolled up to 150 subjects depending on site enrolment rate and patient availability. Up to 2 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients will be identified as having had a surgical procedure involving the Subject Device.
Key inclusion criteria (4 listed)
- Skeletally mature patients at the time of surgery.
- Patients who underwent a craniomaxillofacial procedure using implants of the Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System as per routine clinical practice.
- Patients for whom data on the primary outcome variable is available.
- Patients with data available from follow-up visits.
Key exclusion criteria (5 listed)
- Patients with active infections at the time of surgery.
- Patients with known metal allergies and/or foreign body sensitivity at the time of surgery.
- Subjects with non-reducible and unstable fractures (except reconstruction plates) at the time of surgery that were treated with the subject devices.
- Patients who underwent secondary reconstructions with non-secondary reconstruction plates
- Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery.
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 |
|---|---|---|
| Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF SystemThe Universal CMF System is a plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Depending on the selected module, the design of the devices is more suitable for specific indications within the broad indication of CMF fractures and CMF reconstructive surgeries. | Device | – |
Primary outcome
Successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery
Time frame: Data collected at a single time point per patient in the course of 12 months.
Assessed by reviewing adverse events in patient medical charts at time point after surgery. Used to document whether an unplanned revision surgery was required or not for patients.
7 secondary outcomes
Intraoperative complications
Time frame: Data collected at a single time point per patient in the course of 12 months.
Postoperative complications
Time frame: Data collected at time points per patient in the course of 12 months.
Any known adverse events potentially related to the primary outcome objective and/or device
Time frame: Data collected at time points per patient in the course of 12 months.
Implant failure
Time frame: Data collected at time points point per patient in the course of 12 months.
Operating room (OR) time
Time frame: Data collected at a single time point per patient in the course of 12 months.
Hospitalization time
Time frame: Data collected at a single time point per patient in the course of 12 months.
Post-operative bone consolidation
Time frame: Data collected at time points point per patient in the course of 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zygomatic Fractures and Orbital Fractures, run by Stryker Craniomaxillofacial at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery (time frame: Data collected at a single time point per patient in the course of 12 months.). 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 Apr 2026.