Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up to Confirm Safety, Performance and Effectiveness of The Universal CMF System
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Skeletally mature patients at the time of surgery.
• Patients who underwent a craniomaxillofacial procedure using implants of the Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System as per routine clinical practice.
• Patients for whom data on the primary outcome variable is available.
• Patients with data available from follow-up visits.
Locations
United States
New York
Weill Cornell Medicine Oral and Maxillofacial Surgery 525 East 68th Street, F-2132
RECRUITING
New York
Contact Information
Primary
Ilka Meinert, Ph.D.
ilka.meinert@stryker.com
+49 761 488 8290
Time Frame
Start Date: 2025-03-28
Estimated Completion Date: 2026-02
Participants
Target number of participants: 120
Related Therapeutic Areas
Sponsors
Leads: Stryker Craniomaxillofacial