CompletedNot Applicable

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

United States150 participantsStarted 2025-03-28

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery

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

Trial details

NCT IDNCT07245719

SponsorStryker Craniomaxillofacial

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-03-27

View on ClinicalTrials.gov More Zygomatic Fractures trials