Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up (UPC)

Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up to Confirm Safety and Performance

A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.

Study Overview

• Status: Active, not recruiting
• Conditions: Mandibular Fractures; Facial Fracture; Maxilla Fracture; Orthognathic Surgical Procedures
• Intervention / Treatment: Device: Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery

Detailed Description

This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of Stryker's Facial iD UPC plating system when used in the clinical setting. This study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. Based on a non-inferiority study power calculation a minimum of 80 patients will be enrolled in the study. Additional patients may be enrolled up to 800 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful fixation or reconstruction of the midface without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.

• Study Type: Observational
• Enrollment (Estimated): 726

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • New York Center for Orthognathic and Maxillofacial Surgery
    • New York, New York, United States, 11042
      • New York Center for Orthognathic and Maxillofacial Surgery, Lake Success, New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be identified as having had a surgical procedure involving the Subject Device.

Description

Inclusion Criteria:

1. Patients who received a Stryker UPC plate for osteotomy, stabilization and rigid fixation of maxillofacial fractures or reconstruction as per routine clinical practice
2. Patients for whom data on the primary outcome variable is available.

Exclusion Criteria:

1. Patients with non-reducible and unstable fractures at the time of surgery
2. Patients with fractures of a severely atrophic mandible at the time of surgery
3. Patients with active local infections at the time of surgery
4. Patients with metal allergies and/or foreign body sensitivity at the time of surgery
5. Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery
6. Potentially non-compliant patients who are unwilling or incapable of following postoperative care instructions

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful fixation or reconstruction of the midface without the need for unplanned revision surgery.	Assessed by reviewing adverse events in patient medical charts at time point after surgery. Used to document whether an unplanned revision surgery was required or not for patients.	Data collected at a single time point per patient in the course of 18 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection rate	Determined by adverse events reported from patient medical charts.	Data collected at time points from patient medical charts in the course of 18 months.
Intraoperative complications	Determined by adverse events reported from patient medical charts.	Data collected at a single time point per patient in the course of 18 months.
Postoperative complications	Determined by adverse events reported from patient medical charts.	Data collected at time points per patient in the course of 18 months.
Any known adverse events	Determined by adverse events reported from patient medical charts.	Data collected at time points per patient in the course of 18 months.
Plate failure	Determined by adverse events reported from patient medical charts.	Data collected at time points point per patient in the course of 18 months.
Satisfactory occlusion achieved after additional orthodontic treatment	Data reported in patient medical charts	Data collected at a single time point per patient in the course of 18 months.
Time to return to solid food/normal diet	Time for patient to return to solid food/normal diet post operation (dd)	Data collected at a single time point per patient in the course of 18 months.
Hospitalization time; ICU and normal ward	Time the patient was hospitalized post procedure (dd:hh)	Data collected at a single time point per patient in the course of 18 months.
EuroQol-5 Domain Questionnaire (if available)	A descriptive system and a visual analogue scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with three to five levels of severity. The VAS provides a subjective rating of overall health on a scale from 0 to 100 (higher is better)).	Data collected at time points per patient in the course of 18 months.
Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available)	40 independently functioning scales and checklists. Multiple independent scales, each with a 0-100 score, where higher scores indicate better outcomes. Scores are calculated by summing responses on a 4-point Likert scale (e.g., strongly disagree to strongly agree), which are then converted to the 0-100 range. Each scale measures a specific aspect of facial appearance, quality of life, or adverse effects and cannot be summed into a single total score.	Data collected at time points per patient in the course of 18 months.
12-Item Short Form Health Survey (SF-12)	12 items grouped and scored to produce two separate summary scores: the Physical Component Summary (PCS-12) and the Mental Component Summary (MCS-12). The scale is transformed to a 0-100 range with higher scores indicating better health.	Data collected at time points per patient in the course of 18 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary indication for the surgery / diagnosis	Diagnosis collected from patient medical charts.	Data collected at a single time point per patient in the course of 18 months.
Max follow-up time	Maximum post operative follow up time for patients within standard of care. Reported in patient medical charts during hospital follow up visits.	Data collected at a single time point per patient in the course of 18 months.
Surgical approach	Surgical approach taken for the procedure. Including: transoral; intraoral; maxillary vestibular approach; transbuccal; submandibular; preauricular; other	Data collected at a single time point per patient in the course of 18 months.
Medical conditions	Underlying medical conditions and medication that may be related to the device or primary outcome.	Data collected at time points point per patient in the course of 18 months.
Localization of the defect	Area to treated by the device: mandibular ramus; mandibular body; mandibular condyle; parasymphysis; paramedian; Le Fort I; Le Fort II; Le Fort III; others	Data collected at a single time point per patient in the course of 18 months.
Post operative maxillo-mandibular fixation	For patients that receive maxillo-mandibular fixation post operation the length of time after surgery the fixation procedure took place (days).	Data collected at a single time point per patient in the course of 18 months.
Patient Radiation Exposure	Exposure of patient to radiation therapy within 12 months around the surgery date recorded in patient medical charts (number and type of radiation procedures performed). Radiation therapy performed on the anatomical area treated with the device. Any postoperative radiation therapy recorded in patient medical charts.	Data collected at time points per patient in the course of 18 months.
Sterilization method used	Sterilization method used for the device. Qualitative responses from site.	Data collected at a single time point per patient in the course of 18 months.
Fixation system used	System used to fix the device during the procedure. Stryker Universal CMF screws; others	Data collected at a single time point per patient in the course of 18 months.
Tightening of screws	Tools used to fix the device during the procedure. Response options include : Manual and electric screw driver	Data collected at a single time point per patient in the course of 18 months.
Orthognathic cases	Usage of splints in orthognathic cases.	Data collected at a single time point per patient in the course of 18 months.
Year smoking was stopped	Year smoking was stopped (YYYY)	Data collected at time points per patient in the course of 18 months.
Smoking frequency	The frequency of exposure to smoking during periods of smoking (average number of cigarettes per day).	Data collected at time points per patient in the course of 18 month
Smoking duration	Duration of smoking (pack years)	Data collected at time points per patient in the course of 18 month
Years of active smoking	Total number of years active smoker (YY)	Data collected at time points per patient in the course of 18 month
Patient weight	Weight (kg, lb)	Data collected at a single time point per patient in the course of 18 months.
Patient height	Height (cm, feet, inches)	Data collected at a single time point per patient in the course of 18 months.
Patient age	Age (years)	Data collected at a single time point per patient in the course of 18 months.
Gender	Responses: Male, Female, undifferentiated, unknown	Data collected at a single time point per patient in the course of 18 months

Collaborators and Investigators

• Sponsor: Stryker Craniomaxillofacial

Publications and helpful links

Helpful Links

• Kakarala, Kiran, Yelizaveta Shnayder, Terance T. Tsue, and Douglas A. Girod. 2018. "Mandibular Recon-struction." Oral Oncology.
• Witjes, Max J. H., Rutger H. Schepers, and Joep Kraeima. 2018. "Impact of 3D Virtual Planning on Recon-struction of Mandibular and Maxillary Surgical Defects in Head and Neck Oncology." Current Opinion in Otolaryngology and Head and Neck Surgery.
• Lee, Z. Hye, et al. 2020. "The Latest Evolution in Virtual Surgical Planning: Cus-tomized Reconstruction Plates in Free Fibula Flap M

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: August 1, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mandibular Reconstruction; Orthognathic Surgery; Mandibular Fractures; Mandibular Reconstruction* / Methods
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Mandibular Fractures; Maxillary Fractures
• Other Study ID Numbers: UPC_2023_10_CIP_v 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No