Active — Not RecruitingNot Applicable

Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up

United States726 participantsStarted 2024-11-18

Plain-language summary

A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the 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

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Inclusion criteria

✓. Patients who received a Stryker UPC plate for osteotomy, stabilization and rigid fixation of maxillofacial fractures or reconstruction as per routine clinical practice
✓. Patients for whom data on the primary outcome variable is available.

Exclusion criteria

✕. Patients with non-reducible and unstable fractures at the time of surgery
✕. Patients with fractures of a severely atrophic mandible at the time of surgery
✕. Patients with active local infections at the time of surgery
✕. Patients with metal allergies and/or foreign body sensitivity at the time of surgery
✕. Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery
✕. Potentially non-compliant patients who are unwilling or incapable of following postoperative care instructions

What they're measuring

Successful fixation or reconstruction of the midface without the need for unplanned revision surgery.

Timeframe: Data collected at a single time point per patient in the course of 18 months.

Trial details

NCT IDNCT07245810

SponsorStryker Craniomaxillofacial

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-05-31

View on ClinicalTrials.gov More Mandibular Fractures trials