Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up (UMF)

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.

Study Overview

• Status: Completed
• Conditions: Orbital Fractures; Zygomatic Fractures; Facial Fractures; Maxilla Fractures
• Intervention / Treatment: Device: Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System

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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine Oral and Maxillofacial Surgery 525 East 68th Street, F-2132

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be identified as having had a surgical procedure involving the Subject Device.

Description

Inclusion Criteria:

1. Skeletally mature patients at the time of surgery.
2. 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.
3. Patients for whom data on the primary outcome variable is available.
4. Patients with data available from follow-up visits.

Exclusion Criteria:

1. Patients with active infections at the time of surgery.
2. Patients with known metal allergies and/or foreign body sensitivity at the time of surgery.
3. Subjects with non-reducible and unstable fractures (except reconstruction plates) at the time of surgery that were treated with the subject devices.
4. Patients who underwent secondary reconstructions with non-secondary reconstruction plates
5. Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Data collected at a single time point per patient in the course of 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative complications	Determined by intraoperative adverse events reported from patient medical charts.	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.	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.	Data collected at time points per patient in the course of 12 months.
Implant failure	Determined by adverse events reported from patient medical charts.	Data collected at time points point per patient in the course of 12 months.
Operating room (OR) time	Time patients are operated (dd:hh)	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)	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)	Data collected at time points point per patient in the course of 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking duration	Duration of smoking (pack years)	Data collected at time points per patient in the course of 12 month
Year smoking was stopped	Year smoking was stopped (YYYY)	Data collected at time points per patient in the course of 16 months.
Age	Patient age (year of birth, age in years)	Data collected at a single time point per patient in the course of 12 months.
Primary indication for the surgery / diagnosis	Diagnosis collected from patient medical charts	Data collected at a single time point per patient in the course of 12 months.
Surgical approach/access	Surgical approach taken for the procedure. Including: orthognathic, trauma, oncological, congenital defect, other. Usage of the device in the maxilla and maximal incisal mouth opening (post- and pre-operation). Application of post-operative Maxillo-Mandibular Fixation	Data collected at a single time point per patient in the course of 12 months.
Anatomical area treated	Area to treated by the device: orbital region, zygomatic region, dento-alveolar region, maxilla, frontal region, other.	Data collected at a single time point per patient in the course of 12 months.
Other implants used	Other implants that may have been used during the surgical procedure.	Data collected at time points per patient in the course of 12 months.
Max follow-up time	Maximum post operative follow up time for patients within standard of care. Reported in patient medical charts during hospital follow up visits.	Data collected at a single time point per patient in the course of 12 months.
Orthognathic cases	Satisfactory occlusion expected to be achieved after potential additional orthodontic treatment.	Data collected at a single time point per patient in the course of 12 months.
Patient Radiation Exposure	Exposure of patient to radiation therapy within 12 months around the surgery date recorded in patient medical charts (number and type of radiation procedures performed). Radiation therapy performed on the anatomical area treated with the device. Any postoperative radiation therapy recorded in patient medical charts.	Data collected at time points per patient in the course of 12 months.
Sterilization method used	Sterilization method used for the device. Qualitative responses from site.	Data collected at a single time point per patient in the course of 12 months.
Tightening of screws	Tools used to fix the device during the procedure. Manually, electric screw driver	Data collected at a single time point per patient in the course of 12 months.
Implants Used	Quantity, part numbers & descriptions of implants used from the device.	Data collected at a single time point per patient in the course of 12 months.
Gender	Patient gender (Male, Female, undifferentiated, unknown)	Data collected at a single time point per patient in the course of 12 months.
Height	Patient height (cm, feet, inches)	Data collected at a single time point per patient in the course of 12 months.
Weight	Patient weight (kg, lb)	Data collected at a single time point per patient in the course of 12 months.
Smoking frequency	The frequency of exposure to smoking during periods of smoking (average number of cigarettes per day).	Data collected at time points per patient in the course of 12 months
Years of active smoking	Total number of years active smoker (YY)	Data collected at time points per patient in the course of 12 months

Collaborators and Investigators

• Sponsor: Stryker Craniomaxillofacial

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Actual): March 27, 2026
• Study Completion (Actual): March 27, 2026

Study Registration Dates

• First Submitted: August 7, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Orbital Fractures; Maxillary Fractures; Zygomatic Fractures
• Other Study ID Numbers: Universal CMF System _2023_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No