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

NCT07245719 | Completed FDA Device

• 1 other identifier: Universal CMF System _2023_01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Zygomatic Fractures; Orbital Fractures; Maxilla Fractures; Facial Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Intraoperative complications

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

• Postoperative complications

  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

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

• Implant failure

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

• Operating room (OR) time

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

Other Outcomes (18)

• Age

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

• Primary indication for the surgery / diagnosis

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

• Surgical approach/access

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

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Craniomaxillofacial: lead

Study Sites (1)

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

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Zygomatic Fractures; Orbital Fractures; Maxillary Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Jaw Fractures

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: November 24, 2025
• Study Start: March 28, 2025
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)