CompletedNot Applicable

Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up

United States, Germany70 participantsStarted 2024-12-01

Plain-language summary

A retrospective post market follow up to confirm safety and performance of Stryker's Surgeon iD Plates (SMRP) medical device. 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 underwent primary or secondary mandibular reconstruction using a Stryker Surgeon iD Plate implant as per routine clinical practice.
✓. Patients for whom data on the primary outcome variable is available.

Exclusion criteria

✕. Patients with active local infections at the time of surgery.
✕. Patients with known metal allergies and/or foreign body sensitivity at the time of surgery.
✕. Potentially non-compliant patients who were unwilling or incapable of following post-operative care instructions.
✕. Patients with inadequate bone quantity or quality necessary for plate fixation or stabilization at the time of surgery

What they're measuring

Rate of successful reconstruction of the mandible without the need for unplanned revision surgery compared to benchmark devices in scientific literature.

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

Trial details

NCT IDNCT07221916

SponsorStryker Craniomaxillofacial

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02-27

View on ClinicalTrials.gov More Mandible Fracture trials