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

Completed

Conditions studied: Mandible Fracture, Mandibular Reconstruction

In brief

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.

Key facts

Study ID

NCT07221916

Run by

Stryker Craniomaxillofacial

People needed

70

Starts

2024-12-01

Expected to finish

2026-02-27

Last updated by the study team

2026-04-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UCSF Otolaryngology Head and Neck Surgery — San Francisco, California, United States
• Heinrich-Braun-Klinikum gGmbH — Zwickau, Germany

Full record on ClinicalTrials.gov

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