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

NCT ID: NCT07245719

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-28
• Study Completion Date: 2026-02-28

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.

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.

Conditions

Zygomatic Fractures; Orbital Fractures; Maxilla Fractures; Facial Fractures

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

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

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Craniomaxillofacial

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ilka Meinert, Ph.D.

Role: CONTACT

ilka.meinert@stryker.com

+49 761 488 8290

Facility Contacts

Dr. Gwendolyn Reeve, M.D., Associate Professor

Role: primary

gsr9001@med.cornell.edu

212 746 5175

Other Identifiers

Universal CMF System _2023_01

Identifier Type: -

Identifier Source: org_study_id