Mandible FractureSMRPNCT07221916
Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up
An observational study of Mandible Fracture and Mandibular Reconstruction, run by Stryker Craniomaxillofacial at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandible Fracture, Mandibular Reconstruction
- What is being tested?
- Mandibular Reconstruction
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2024to 27 Feb 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 Surgeon iD Plate 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
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
UCSF Otolaryngology Head and Neck Surgery
San Francisco, California, 94143
About this study
Official title: Stryker Customized Plates for Mandibular Reconstruction: A Retrospective Post Market Follow Up to Confirm Safety and Performance of Surgeon iD Mandible Reconstruction Plates
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.
Read the detailed description
This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of Stryker's Surgeon iD Mandible Recon Plate when used in the clinical setting. This study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively.
Based on a non-inferiority study power calculation a minimum of 27 patients will be enrolled in the study. Additional patients may be enrolled up to 80 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States and one in the EU will participate in this study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be assessed at all available follow-up timepoints for included patients.
- Conditions
- Mandible Fracture, Mandibular Reconstruction
- Being tested
- Mandibular Reconstruction
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular ReconstructionDevice
Also called Mandibular Fracture Fixation
Mandibular Reconstruction or mandibular fracture fixation using a Surgeon iD Mandible Reconstruction Plate (referred to as Surgeon iD Plates).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data collected at a single time point per patient in the course of 12 months
Secondary outcomes (13)
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 12 months.
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 12 months.
Postoperative complications
Determined by adverse events reported from patient medical charts.
Measured: Data collected at time points per patient in the course of 12 months.
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 12 months.
Rate of Plate failure
Determined by adverse events reported from patient medical charts.
Measured: Data collected at time points per patient in the course of 12 months.
Operating room (OR) time
Time patients are operated (hh:mm)
Measured: Data collected at a single time point per patient in the course of 12 months.
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 12 months.
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 time points per patient in the course of 12 months.
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 12 months.
Short-form-12-health-survey-questionnaire (if available)
Short-form-12-health-survey-Questionnaire (Scale of 0-100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health).
Measured: Data collected at time points per patient in the course of 12 months.
Ischemia time
Ischemia time (dd:hh)
Measured: Data collected at a single time point per patient in the course of 12 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)).
Measured: Data collected at time points per patient in the course of 12 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.
Measured: Data collected at time points per patient in the course of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start1 Dec 2024
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Craniomaxillofacial
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221916
- Sponsor's protocol ID
- Surgeon iD Plates _2023_01
- Acronym
- SMRP
- 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
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stryker Customized Plates for Mandibular Reconstruction: A Retrospective Post Market Follow Up to Confirm Safety and Performance of Surgeon iD Mandible Reconstruction Plates
- ClinicalTrials.gov ID
- NCT07221916
- Acronym / sponsor ID
- SMRP / Surgeon iD Plates _2023_01
- Conditions
- Mandible Fracture, Mandibular Reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Stryker CraniomaxillofacialIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of Stryker's Surgeon iD Mandible Recon Plate when used in the clinical setting. This study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively.
Based on a non-inferiority study power calculation a minimum of 27 patients will be enrolled in the study. Additional patients may be enrolled up to 80 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States and one in the EU will participate in this study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be assessed at all available follow-up timepoints for included patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients will be identified as having had a surgical procedure involving the Subject Device.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular ReconstructionAlso: Mandibular Fracture FixationMandibular Reconstruction or mandibular fracture fixation using a Surgeon iD Mandible Reconstruction Plate (referred to as Surgeon iD Plates). | Device | – |
Primary outcome
Rate of successful reconstruction of the mandible without the need for unplanned revision surgery compared to benchmark devices in scientific literature.
Time frame: Data collected at a single time point per patient in the course of 12 months
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.
13 secondary outcomes
Infection rate
Time frame: Data collected at time points from patient medical charts in the course of 12 months.
Intraoperative complications
Time frame: Data collected at a single time point per patient in the course of 12 months.
Postoperative complications
Time frame: Data collected at time points per patient in the course of 12 months.
Any known adverse events
Time frame: Data collected at time points per patient in the course of 12 months.
Rate of Plate failure
Time frame: Data collected at time points per patient in the course of 12 months.
Operating room (OR) time
Time frame: Data collected at a single time point per patient in the course of 12 months.
Time to return to solid food/normal diet
Time frame: Data collected at a single time point per patient in the course of 12 months.
Rate of satisfactory occlusion achieved with orthodontic treatment.
Time frame: Data collected at time points per patient in the course of 12 months.
Hospitalization time: ICU and normal ward
Time frame: Data collected at a single time point per patient in the course of 12 months.
Short-form-12-health-survey-questionnaire (if available)
Time frame: Data collected at time points per patient in the course of 12 months.
Ischemia time
Time frame: Data collected at a single time point per patient in the course of 12 months.
EuroQol-5 Domain Questionnaire (if available)
Time frame: Data collected at time points per patient in the course of 12 months.
Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available)
Time frame: Data collected at time points per patient in the course of 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Kakarala, Kiran, Yelizaveta Shnayder, Terance T. Tsue, and Douglas A. Girod. 2018. "Mandibular Recon-struction." Oral Oncology.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandible Fracture and Mandibular Reconstruction, run by Stryker Craniomaxillofacial at 2 sites in 2 countries.
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 2 sites in United States, Germany. 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 compared to benchmark devices in scientific literature. (time frame: Data collected at a single time point per patient in the course of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.