Facial iD Customized Mandible Reconstruction Plates

NCT07245758 | Completed FDA Device

• 1 other identifier: CMRP_2023_01_CIP_v 1.0
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mandibular Fractures; Mandible Fracture; Mandible; Deformity; MANDIBLE; Orthognathic Surgical Procedures

Keywords

Mandibular Reconstruction; Reconstruction Plate; Orthognathic Surgery; Mandibular Reconstruction* / Methods

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

  Data collected at time points from patient medical charts in the course of 16 months.

• Intraoperative complications

  Data collected at a single time point per patient in the course of 16 months.

• Postoperative complications

  Data collected at time points per patient in the course of 16 months.

• Any known adverse events

  Data collected at time points per patient in the course of 16 months.

Other Outcomes (20)

• Follow-up time

  Data collected at a single time point per patient in the course of 16 months.

• Flap used

  Data collected at a single time point per patient in the course of 16 months.

• Radiation

  Data collected at time points per patient in the course of 16 months.

Interventions

Mandibular reconstruction DEVICE

Primary or secondary reconstruction of the mandible using customized Mandible Reconstruction Plate (referred to as CMRP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients who underwent primary or secondary mandibular reconstruction using a Stryker Facial iD CMRP implant as per routine clinical practice.
• Patients for whom data on the primary outcome variable is available.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Craniomaxillofacial: lead

Study Sites (1)

Head & Neck Surgery Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Related Publications (5)

• 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.

  PMID: 30115476 BACKGROUND

• 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.

  PMID: 34900674 BACKGROUND

• 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.

  PMID: 29470184 BACKGROUND

• 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.

  PMID: 32590512 BACKGROUND

• 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.

  PMID: 29362116 BACKGROUND

MeSH Terms

Conditions

Mandibular Fractures; Congenital Abnormalities

Interventions

Mandibular Reconstruction

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthognathic Surgical Procedures; Oral Surgical Procedures; Dentistry

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2024
• Primary Completion: April 4, 2026
• Study Completion: April 4, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)