Mandibular FracturesUPCNCT07245810
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
An observational study of Mandibular Fractures and Facial Fracture, run by Stryker Craniomaxillofacial at 2 sites in United States.
Trial summary
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the 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
- Mandibular Fractures, Facial Fracture, Maxilla Fracture
- What is being tested?
- Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
- Type of treatment
- Medical device
- How many people
- 726 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Nov 2024to 31 May 2026
- Phase
- Observational
- 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
Study population: Eligible patients will be identified as having had a surgical procedure involving the Subject Device.
Who may be able to join
- Patients who received a Stryker UPC plate for osteotomy, stabilization and rigid fixation of maxillofacial fractures or reconstruction as per routine clinical practice
- Patients for whom data on the primary outcome variable is available.
Who cannot join
- Patients with non-reducible and unstable fractures at the time of surgery
- Patients with fractures of a severely atrophic mandible at the time of surgery
- Patients with active local infections at the time of surgery
- Patients with metal allergies and/or foreign body sensitivity at the time of surgery
- Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery
- Potentially non-compliant patients who are unwilling or incapable of following postoperative care instructions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York Center for Orthognathic and Maxillofacial Surgery
New York, New York, 10022
New York Center for Orthognathic and Maxillofacial Surgery, Lake Success, New York
New York, New York, 11042
About this study
Official title: Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up to Confirm Safety and Performance
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the 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 Stryker's Facial iD UPC plating system when used in the 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 80 patients will be enrolled in the study. Additional patients may be enrolled up to 800 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful fixation or reconstruction of the midface without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.
- Being tested
- Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
- Keywords
- Orthognathic Surgery, Mandibular Reconstruction, Mandibular Fractures, Mandibular Reconstruction* / Methods
- Medical subject headings
- Mandibular Fractures, Maxillary Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgeryDevice
Osteotomy, Mandible and Maxillofacial reconstruction, Orthognathic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful fixation or reconstruction of the midface 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 18 months.
Secondary outcomes (11)
Infection rate
Determined by adverse events reported from patient medical charts.
Measured: Data collected at time points from patient medical charts in the course of 18 months.
Intraoperative complications
Determined by adverse events reported from patient medical charts.
Measured: Data collected at a single time point per patient in the course of 18 months.
Postoperative complications
Determined by adverse events reported from patient medical charts.
Measured: Data collected at time points per patient in the course of 18 months.
Any known adverse events
Determined by adverse events reported from patient medical charts.
Measured: Data collected at time points per patient in the course of 18 months.
Plate failure
Determined by adverse events reported from patient medical charts.
Measured: Data collected at time points point per patient in the course of 18 months.
Satisfactory occlusion achieved after additional orthodontic treatment
Data reported in patient medical charts
Measured: Data collected at a single time point per patient in the course of 18 months.
Time to return to solid food/normal diet
Time for patient to return to solid food/normal diet post operation (dd)
Measured: Data collected at a single time point per patient in the course of 18 months.
Hospitalization time; ICU and normal ward
Time the patient was hospitalized post procedure (dd:hh)
Measured: Data collected at a single time point per patient in the course of 18 months.
EuroQol-5 Domain Questionnaire (if available)
A descriptive system and a visual analogue scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with three to five levels of severity. The VAS provides a subjective rating of overall health on a scale from 0 to 100 (higher is better)).
Measured: Data collected at time points per patient in the course of 18 months.
Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available)
40 independently functioning scales and checklists. Multiple independent scales, each with a 0-100 score, where higher scores indicate better outcomes. Scores are calculated by summing responses on a 4-point Likert scale (e.g., strongly disagree to strongly agree), which are then converted to the 0-100 range. Each scale measures a specific aspect of facial appearance, quality of life, or adverse effects and cannot be summed into a single total score.
Measured: Data collected at time points per patient in the course of 18 months.
12-Item Short Form Health Survey (SF-12)
12 items grouped and scored to produce two separate summary scores: the Physical Component Summary (PCS-12) and the Mental Component Summary (MCS-12). The scale is transformed to a 0-100 range with higher scores indicating better health.
Measured: Data collected at time points per patient in the course of 18 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 start18 Nov 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular 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
- 726 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stryker Craniomaxillofacial
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245810
- Sponsor's protocol ID
- UPC_2023_10_CIP_v 1.0
- Acronym
- UPC
- Status last verified
- Apr 2026
- First submitted
- 1 Aug 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up to Confirm Safety and Performance
- ClinicalTrials.gov ID
- NCT07245810
- Acronym / sponsor ID
- UPC / UPC_2023_10_CIP_v 1.0
- Keywords
- Orthognathic Surgery, Mandibular Reconstruction, Mandibular Fractures, Mandibular Reconstruction* / Methods
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 726 participants (estimated)
- Lead sponsor
- Stryker CraniomaxillofacialIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- 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 follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the 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 Stryker's Facial iD UPC plating system when used in the 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 80 patients will be enrolled in the study. Additional patients may be enrolled up to 800 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful fixation or reconstruction of the midface 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 (2 listed)
- Patients who received a Stryker UPC plate for osteotomy, stabilization and rigid fixation of maxillofacial fractures or reconstruction as per routine clinical practice
- Patients for whom data on the primary outcome variable is available.
Key exclusion criteria (6 listed)
- Patients with non-reducible and unstable fractures at the time of surgery
- Patients with fractures of a severely atrophic mandible at the time of surgery
- Patients with active local infections at the time of surgery
- Patients with metal allergies and/or foreign body sensitivity at the time of surgery
- 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 |
|---|---|---|
| Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgeryOsteotomy, Mandible and Maxillofacial reconstruction, Orthognathic surgery | Device | – |
Primary outcome
Successful fixation or reconstruction of the midface without the need for unplanned revision surgery.
Time frame: Data collected at a single time point per patient in the course of 18 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.
11 secondary outcomes
Infection rate
Time frame: Data collected at time points from patient medical charts in the course of 18 months.
Intraoperative complications
Time frame: Data collected at a single time point per patient in the course of 18 months.
Postoperative complications
Time frame: Data collected at time points per patient in the course of 18 months.
Any known adverse events
Time frame: Data collected at time points per patient in the course of 18 months.
Plate failure
Time frame: Data collected at time points point per patient in the course of 18 months.
Satisfactory occlusion achieved after additional orthodontic treatment
Time frame: Data collected at a single time point per patient in the course of 18 months.
Time to return to solid food/normal diet
Time frame: Data collected at a single time point per patient in the course of 18 months.
Hospitalization time; ICU and normal ward
Time frame: Data collected at a single time point per patient in the course of 18 months.
EuroQol-5 Domain Questionnaire (if available)
Time frame: Data collected at time points per patient in the course of 18 months.
Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available)
Time frame: Data collected at time points per patient in the course of 18 months.
12-Item Short Form Health Survey (SF-12)
Time frame: Data collected at time points per patient in the course of 18 months.
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 Apr 2026.
- Kakarala, Kiran, Yelizaveta Shnayder, Terance T. Tsue, and Douglas A. Girod. 2018. "Mandibular Recon-struction." Oral Oncology.Link provided by the sponsor.
- Lee, Z. Hye, et al. 2020. "The Latest Evolution in Virtual Surgical Planning: Cus-tomized Reconstruction Plates in Free Fibula Flap MLink provided by the sponsor.
- Witjes, Max J. H., Rutger H. Schepers, and Joep Kraeima. 2018. "Impact of 3D Virtual Planning on Recon-struction of Mandibular and Maxillary Surgical Defects in Head and Neck Oncology." Current Opinion in Otolaryngology and Head and Neck Surgery.Link provided by the sponsor.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Fractures and Facial Fracture, run by Stryker Craniomaxillofacial at 2 sites 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 2 inclusion and 6 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: under way, not looking for participants, 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 2 sites 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?
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?
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 fixation or reconstruction of the midface without the need for unplanned revision surgery. (time frame: Data collected at a single time point per patient in the course of 18 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.