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Mandibular FracturesNCT07245758

Facial iD Customized Mandible Reconstruction Plates

An observational study of Mandibular Fractures and Mandible Fracture, run by Stryker Craniomaxillofacial at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Mandibular reconstruction
Type of treatment
Medical device
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Dec 2024to 4 Apr 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Head & Neck Surgery Medical University of South Carolina

    Charleston, South Carolina, 29403

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Mandibular reconstruction
Keywords
Mandibular Reconstruction, Reconstruction Plate, Orthognathic Surgery, Mandibular Reconstruction* / Methods
Medical subject headings
Mandibular Fractures, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mandibular reconstructionDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (17)

  1. 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.

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

  2. Infection rate

    Determined by adverse events reported from patient medical charts.

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

  3. Intraoperative complications

    Determined by adverse events reported from patient medical charts.

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

  4. Postoperative complications

    Determined by adverse events reported from patient medical charts.

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

  5. Any known adverse events

    Determined by adverse events reported from patient medical charts.

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

  6. Rate of plate or screw failure

    Determined by rate of adverse events reported from patient medical charts involving plate or screw fracture.

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

  7. Operating room (OR) time

    Time patients are operated (dd:hh)

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

  8. Time to return to solid food/normal diet

    Time for patient to return to solid food/normal diet post operation (dd)

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

  9. Hospitalization time: ICU and normal ward

    Time the patient was hospitalized post procedure (dd:hh)

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

  10. 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)).

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

  11. 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.

    Measured: Data collected during the course of 16 months.

  12. Misfit of implant

    Fit of implant Time for adaptations

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

  13. 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.

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

  14. 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.

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

  15. 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.

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

  16. Ischemia time

    Ischemia time (dd:hh)

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

  17. Frequency of Maxilla-mandibular fixation

    Number of maxillo-mandibular fixation procedures (number per patient).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start1 Dec 2024
  3. Primary completion4 Apr 2026
  4. Study completion4 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07245758
Sponsor's protocol ID
CMRP_2023_01_CIP_v 1.0
Status last verified
Apr 2026
First submitted
31 Jul 2025
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

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.

    PubMed 30115476

  • 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.

    PubMed 34900674

  • 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.

    PubMed 29470184

  • 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.

    PubMed 32590512

  • 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.

    PubMed 29362116

Questions about this trial

What is this clinical trial studying?

An observational study of Mandibular Fractures and Mandible Fracture, run by Stryker Craniomaxillofacial at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of successful reconstruction of the mandible without the need for unplanned revision surgery (time frame: Data collected at a single time point per patient in the course of 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07245758, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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