CompletedNot Applicable

Facial iD Customized Mandible Reconstruction Plates

United States50 participantsStarted 2024-12-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of successful reconstruction of the mandible without the need for unplanned revision surgery

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

Trial details

NCT IDNCT07245758

SponsorStryker Craniomaxillofacial

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-04-04

View on ClinicalTrials.gov More Mandibular Fractures trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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