Facial iD Customized Mandible Reconstruction Plates

Stryker Customized Plates for Mandibular Reconstruction: A Retrospective Post Market Follow Up to Confirm Safety and Performance of Facial iD Customized Mandible Reconstruction Plates

A retrospective post market follow up to confirm the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.

Study Overview

• Status: Completed
• Conditions: Mandible; Deformity; Mandible Fracture; Mandibular Fractures; MANDIBLE; Orthognathic Surgical Procedures
• Intervention / Treatment: Device: Mandibular reconstruction

Detailed Description

This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of Stryker Customized Plates for Mandibular Reconstruction (CMRP) in the clinical setting. his study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. Up to 3 investigational sites in US will be participating. Based on a non-inferiority study power calculation 80 subjects will be enrolled in the study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Head & Neck Surgery Medical University of South Carolina

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 underwent primary or secondary mandibular reconstruction using a Stryker Facial iD CMRP 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful reconstruction of the mandible without the need for unplanned revision surgery	Rate of unplanned revision surgery determined by reviewing adverse events in patient medical charts after surgery. Used to document whether an unplanned revision surgery was required or not for each patient.	Data collected at a single time point per patient in the course of 16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of satisfactory occlusion achieved with orthodontic treatment.	Assessed by review of individual patient medical records that document the rate of satisfactory occlusion achieved with orthodontic treatment.	Data collected at a single time point per patient in the course of 16 months.
Infection rate	Determined by adverse events reported from patient medical charts.	Data collected at time points from patient medical charts in the course of 16 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 16 months.
Postoperative complications	Determined by adverse events reported from patient medical charts.	Data collected at time points per patient in the course of 16 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 16 months.
Rate of plate or screw failure	Determined by rate of adverse events reported from patient medical charts involving plate or screw fracture.	Data collected at time points point per patient in the course of 16 months.
Operating room (OR) time	Time patients are operated (dd:hh)	Data collected at a single time point per patient in the course of 16 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 16 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 16 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 16 months.
End user questionnaire	Questionnaire only for medically trained professionals on site staff using the device. Questions relate to subjective rating of ease of use by the surgeon if compared to stock plates (evaluated per treating surgeon, not per patient). Questionnaire is qualitative response regarding the ease of use of the device.	Data collected during the course of 16 months.
Misfit of implant	Fit of implant Time for adaptations	Data collected at time points per patient in the course of 16 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 16 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 16 months.
Visual Analogue Scale (VAS) Pain	The visual analogue scale (VAS) is a psychometric response scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.	Data collected at time points per patient in the course of 16 months.
Ischemia time	Ischemia time (dd:hh)	Data collected at a single time point per patient in the course of 16 months.
Frequency of Maxilla-mandibular fixation	Number of maxillo-mandibular fixation procedures (number per patient).	Data collected at time points per patient in the course of 16 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical approach	Surgical approach taken for the procedure. Including: transoral; transbuccal; submandibular; preauricular; other	Data collected at a single time point per patient in the course of 16 months.
Follow-up time	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 16 months.
Flap used	Type of flap used: vascularized fibula flap, vascularized scapula flap, vascularized iliac crest flap, avascularized fibula flap, avascularized scapula flap, avascularized iliac crest flap, others	Data collected at a single time point per patient in the course of 16 months.
Radiation	Exposure of patient to radiation therapy within 12 months around the surgery date recorded in patient medical charts. 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 16 months.
Dental reconstruction in a single stage surgery	Data for dental reconstruction collected from patient medical charts.	Data collected at time points per patient in the course of 16 months.
Sterilization method used	Sterilization method used for the device.	Data collected at a single time point per patient in the course of 16 months.
Fixation system used	System used to fix the device during the procedure. Stryker Universal Mandible System; other Types and number of screws	Data collected at a single time point per patient in the course of 18 months.
Plate types	2.0 or 2.8 plates used Hemi or full reconstruction plate used	Data collected at a single time point per patient in the course of 16 months.
Patient age	Age (years)	Data collected at a single time point per patient in the course of 16 months.
Gender	Responses: Male, Female, undifferentiated, unknown	Data collected at a single time point per patient in the course of 16 months
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 16 months.
Relevant Medical conditions	Descriptive data of any underlying medical conditions and medications recorded in patient medical charts that may be related to the device or primary outcome (qualitative measure).	Data collected at time points per patient in the course of 16 months.
Primary/secondary reconstruction performed	Type of reconstruction procedure performed (e.g. immediately or after an initial surgery).	Data collected at time points point per patient in the course of 16 months
Localization of the defect	Area to treated by the device: mandibular ramus; mandibular body; mandibular condyle; parasymphysis; paramedian; other	Data collected at time points point per patient in the course of 16 months.
Patient height	Height (cm, feet, inches)	Data collected at a single time point per patient in the course of 16 months.
Patient weight	Weight (kg, lb)	Data collected at a single time point per patient in the course of 16 months.
Year smoking was stopped	Year smoking was stopped (YYYY)	Data collected at time points per patient in the course of 16 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 16 month
Smoking duration	Duration of smoking (pack years)	Data collected at time points per patient in the course of 16 month
Years of active smoking	Total number of years active smoker (YY)	Data collected at time points per patient in the course of 16 month

Collaborators and Investigators

• Sponsor: Stryker Craniomaxillofacial

Publications and helpful links

General Publications

• van Baar GJC, Forouzanfar T, Liberton NPTJ, Winters HAH, Leusink FKJ. Accuracy of computer-assisted surgery in mandibular reconstruction: A systematic review. Oral Oncol. 2018 Sep;84:52-60. doi: 10.1016/j.oraloncology.2018.07.004. Epub 2018 Jul 20.
• Mollmann HL, Apeltrath L, Karnatz N, Wilkat M, Riedel E, Singh DD, Rana M. Comparison of the Accuracy and Clinical Parameters of Patient-Specific and Conventionally Bended Plates for Mandibular Reconstruction. Front Oncol. 2021 Nov 26;11:719028. doi: 10.3389/fonc.2021.719028. eCollection 2021.
• Witjes MJH, Schepers RH, Kraeima J. Impact of 3D virtual planning on reconstruction of mandibular and maxillary surgical defects in head and neck oncology. Curr Opin Otolaryngol Head Neck Surg. 2018 Apr;26(2):108-114. doi: 10.1097/MOO.0000000000000437.
• Lee ZH, Alfonso AR, Ramly EP, Kantar RS, Yu JW, Daar D, Hirsch DL, Jacobson A, Levine JP. The Latest Evolution in Virtual Surgical Planning: Customized Reconstruction Plates in Free Fibula Flap Mandibular Reconstruction. Plast Reconstr Surg. 2020 Oct;146(4):872-879. doi: 10.1097/PRS.0000000000007161.
• Kakarala K, Shnayder Y, Tsue TT, Girod DA. Mandibular reconstruction. Oral Oncol. 2018 Feb;77:111-117. doi: 10.1016/j.oraloncology.2017.12.020. Epub 2018 Jan 4.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): April 4, 2026
• Study Completion (Actual): April 4, 2026

Study Registration Dates

• First Submitted: July 31, 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 Reconstruction* / Methods; Reconstruction Plate
• 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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Congenital Abnormalities; Mandibular Fractures; Dentistry; Oral Surgical Procedures; Orthognathic Surgical Procedures; Mandibular Reconstruction
• Other Study ID Numbers: CMRP_2023_01_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