Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up

NCT07221916 | Completed

• 1 other identifier: Surgeon iD Plates _2023_01
• Study Type: observational
• Target: 70
• Locations: 2 countries
• Sites: 2

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 systematically collecting clinical data on its use.

Conditions

Mandible Fracture; Mandibular Reconstruction

Outcome Measures

Primary Outcomes (1)

• Rate of successful reconstruction of the mandible without the need for unplanned revision surgery compared to benchmark devices in scientific literature.

  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 12 months

Secondary Outcomes (13)

• Infection rate

  Data collected at time points from patient medical charts in the course of 12 months.

• Intraoperative complications

  Data collected at a single time point per patient in the course of 12 months.

• Postoperative complications

  Data collected at time points per patient in the course of 12 months.

• Any known adverse events

  Data collected at time points per patient in the course of 12 months.

• Rate of Plate failure

  Data collected at time points per patient in the course of 12 months.

Other Outcomes (22)

• Patient age

  Data collected at a single time point per patient in the course of 12 months.

• Primary indication for the surgery / diagnosis

  Data collected at a single time point per patient in the course of 12 months.

• Follow-up time

  Data collected at a single time point per patient in the course of 12 months.

Interventions

Mandibular Reconstruction DEVICE

Mandibular Reconstruction or mandibular fracture fixation using a Surgeon iD Mandible Reconstruction Plate (referred to as Surgeon iD Plates).

Also known as: Mandibular Fracture Fixation

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 Surgeon iD Plate 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 (2)

UCSF Otolaryngology Head and Neck Surgery

San Francisco, California, 94143, United States

Location

Heinrich-Braun-Klinikum gGmbH

Zwickau, 08060, Germany

Location

Related Links

• Kakarala, Kiran, Yelizaveta Shnayder, Terance T. Tsue, and Douglas A. Girod. 2018. "Mandibular Recon-struction." Oral Oncology.
• Lee,Z. et. al.2020. "The Latest Evolution in Virtual Surgical Planning: Customized Reconstruction Plates in Free Fibula Flap Mandibular Reconstruction." Plastic and Reconstructive Surgery.
• 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.
• Zeller AN, et al. Correction to: Patient-Specific Mandibular Reconstruction Plates Increase Accuracy and Long-Term Stability in Immediate Alloplastic Reconstruction of Segmental Mandibular Defects. J Maxillofac Oral Surg. 2022 Dec;21(4):1096.
• Möllmann HL, et al. Comparison of the Accuracy and Clinical Parameters of Patient-Specific and Conventionally Bended Plates for Mandibular Reconstruction. Front Oncol. 2021 Nov 26;11:719028.
• van Baar, et al, 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.

MeSH Terms

Conditions

Mandibular Fractures

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

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: October 28, 2025
• Study Start: December 1, 2024
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1); DE (1)