Status:
RECRUITING
Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up
Lead Sponsor:
Stryker Craniomaxillofacial
Conditions:
Mandible Fracture
Mandibular Reconstruction
Eligibility:
All Genders
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 ...
Detailed Description
This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of Stryker's Surgeon iD Mandible Recon Plate when used in the clinical setting. This study ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07221916
Start Date
December 1 2024
End Date
December 31 2025
Last Update
October 28 2025
Active Locations (2)
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1
UCSF Otolaryngology Head and Neck Surgery
San Francisco, California, United States, 94143
2
Heinrich-Braun-Klinikum gGmbH
Zwickau, Germany, 08060