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Completed

NCT Number: NCT07245719

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

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.

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Key information

Conditions

Zygomatic Fractures Craniocerebral Trauma Facial Fractures Facial Injuries Fractures, Bone Jaw Fractures Maxilla Fractures Maxillary Fractures Maxillofacial Injuries Nervous System Diseases Orbital Fractures Skull Fractures Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Weill Cornell Medicine Oral and Maxillofacial Surgery 525 East 68th Street, F-2132

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intraoperative complications

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Determined by intraoperative adverse events reported from patient medical charts.

  2. Postoperative complications

    Time frame: Data collected at time points per patient in the course of 12 months.

    Determined by post operative adverse events reported from patient medical charts.

  3. 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.

    Determined by adverse events reported from patient medical charts.

  4. Implant failure

    Time frame: Data collected at time points point per patient in the course of 12 months.

    Determined by adverse events reported from patient medical charts.

  5. Operating room (OR) time

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Time patients are operated (dd:hh)

  6. Hospitalization time

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Time the patient was hospitalized post procedure (ICU and normal ward; dd:hh)

  7. Post-operative bone consolidation

    Time frame: Data collected at time points point per patient in the course of 12 months.

    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)

Other outcomes

  1. Age

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Patient age (year of birth, age in years)

  2. Primary indication for the surgery / diagnosis

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Diagnosis collected from patient medical charts

  3. Surgical approach/access

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    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

  4. Anatomical area treated

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Area to treated by the device: orbital region, zygomatic region, dento-alveolar region, maxilla, frontal region, other.

  5. Other implants used

    Time frame: Data collected at time points per patient in the course of 12 months.

    Other implants that may have been used during the surgical procedure.

  6. Max follow-up time

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Maximum post operative follow up time for patients within standard of care. Reported in patient medical charts during hospital follow up visits.

  7. Orthognathic cases

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Satisfactory occlusion expected to be achieved after potential additional orthodontic treatment.

  8. Patient Radiation Exposure

    Time frame: Data collected at time points per patient in the course of 12 months.

    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.

  9. Sterilization method used

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Sterilization method used for the device. Qualitative responses from site.

  10. Tightening of screws

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Tools used to fix the device during the procedure. Manually, electric screw driver

  11. Implants Used

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Quantity, part numbers & descriptions of implants used from the device.

  12. Gender

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Patient gender (Male, Female, undifferentiated, unknown)

  13. Height

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Patient height (cm, feet, inches)

  14. Weight

    Time frame: Data collected at a single time point per patient in the course of 12 months.

    Patient weight (kg, lb)

  15. Year smoking was stopped

    Time frame: Data collected at time points per patient in the course of 16 months.

    Year smoking was stopped (YYYY)

  16. Smoking frequency

    Time frame: Data collected at time points per patient in the course of 12 months

    The frequency of exposure to smoking during periods of smoking (average number of cigarettes per day).

  17. Smoking duration

    Time frame: Data collected at time points per patient in the course of 12 month

    Duration of smoking (pack years)

  18. Years of active smoking

    Time frame: Data collected at time points per patient in the course of 12 months

    Total number of years active smoker (YY)

Sponsors and collaborators

Lead sponsor

Stryker Craniomaxillofacial

Industry

Registry information

Official study 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

Acronym: UMF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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