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Recruiting NCT07221916

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

Trial Parameters

Condition Mandible Fracture
Sponsor Stryker Craniomaxillofacial
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2024-12-01
Completion 2025-12-31
Interventions
Mandibular Reconstruction

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Patients who underwent primary or secondary mandibular reconstruction using a Stryker Surgeon iD Plate implant as per routine clinical practice. 2. Patients for whom data on the primary outcome variable is available. Exclusion Criteria: 1. Patients with active local infections at the time of surgery. 2. Patients with known metal allergies and/or foreign body sensitivity at the time of surgery. 3. Potentially non-compliant patients who were unwilling or incapable of following post-operative care instructions. 4. Patients with inadequate bone quantity or quality necessary for plate fixation or stabilization at the time of surgery

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