TumorNCT04931056
A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.
An observational study of Tumor and Facial Fracture, run by Zimmer Biomet at 1 site in Argentina.
Trial summary
This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tumor, Facial Fracture, Mandibular Fractures
- What is being tested?
- Titanium Facial Plates, Titanium Mandibular Plates and Add-on Condyle
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Oct 2021to 30 Nov 2023
- 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 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Subjects, who underwent a facial, orbital, or midface procedure and received plates, screws and/or mesh manufactured by Biomet Microfixation. All enrolled subjects will provide data from a retrospective chart review on outcomes of interest.
Who may be able to join
- Males or females
- A patient who underwent one or more of the following surgical procedures completed between January 1, 2015 and December 31, 2019, with plates, screws, and or meshes from the Biomet Microfixation Facial Plating System:
- Repair of a facial fracture
- Repair of a facial osteotomy
- Reconstructive procedures of the facial skeleton
- Revision procedures where other treatments or devices have failed
- Available follow-up data at least at 30 days' post-operative
Who cannot join
- Active or latent infection at the time of implantation
- Documented foreign body sensitivity
- Patients with limited blood supply, insufficient quantity or quality of bone (e.g., osteomalacia or a bone resorption condition such as Paget's disease, osteoporosis, bone metastasis)
- Patients with documented mental or neurologic conditions who were unwilling or incapable of following postoperative care instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Biomet Microfixation Devices Used in Facial & Mandibular Surgical Procedures. Facial Plating System, HTR PEKK (Midface) and Mandibular Plates: A Post Market Clinical Follow-up Study
This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.
Read the detailed description
The subject devices are:
- plates, screws, and primary instruments from the Biomet Microfixation Facial Plating System, including plates to be specifically used in orthognathic procedures
- plates, screws and primary instruments for the Mandibular Plating System, including and a device intended to temporarily restore the functionality of the temporomandibular joint for patients whose natural condyle has to be resected, subsequent to a tumor ablation ("Add-On Condyle") Additionally, a third device intended for the replacement of bony voids in the facial skeleton will be evaluated in this trial (HTR-PEKK- facial application).
- Conditions
- Tumor, Facial Fracture, Mandibular Fractures, Fibrous Dysplasia, Osteoma of Mandibular Condyle, Neuroma
- Being tested
- Titanium Facial Plates, Titanium Mandibular Plates, Add-on Condyle, HTR-PEKK
- Keywords
- facial plates, mandibular reconstruction, facial reconstruction, condylar tumor, orofacial cleft
- Medical subject headings
- Neoplasms, Mandibular Fractures, Fibrous Dysplasia of Bone, Neuroma, Goldenhar Syndrome, Mandibulofacial Dysostosis, Genee-Wiedemann syndrome, Acrofacial dysostosis, Nager type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium Facial PlatesDevice
Also called Titanium facial mini plates
The Facial Plating System provides a comprehensive titanium fixation solution for maxillofacial surgery procedures. More than twenty-five different plating options in two systems, the 1.5 mm and 2.0 mm with a variety of instruments, and high torque screws, including meshes, are part of this system. Plates and screws are made of commercially pure titanium per ASTM F-67, Titanium 6Al 4V Alloy per ASTM F-136.
Titanium Mandibular PlatesDevice
Also called Titanium mandibular mini plates
The Mandibular Plating System provides a comprehensive titanium fixation solution for mandibular surgical procedures. Several plating options, a variety of instruments, and high torque screws with various plate shapes are part of this system.
Plates in the Mandibular Plating System have profiles of various thicknesses. Screws are available in self-tapping, locking and non-locking varieties, and in various sizes between 2.0 mm and 2.3 mm in diameter, and 5 mm to 18 mm in length.
Add-on CondyleDevice
The Add-On Condyle is intended to be implanted in the human jaw to replace the mandibular condyle to functionally reconstruct the temporomandibular joint on a temporary basis for patients undergoing ablative tumor surgery requiring the removal of the native mandibular condyle. This device is not for permanent implantation, traumatic injuries, or for treatment of temporomandibular joint disease.
HTR-PEKKDevice
The HTR-PEKK implants are fabricated from polyether-ketone-ketone (PEKK) via selective laser sintering (SLS), a 3D manufacturing technique. The laser sintering machine builds the implant in layers as dictated from a stereolithographic (STL) file of the approved implant. The HTR-PEKK implants are designed individually for each patient to replace bony voids in the facial anatomy using a patient's own CT imaging data. The implant is made to fill an existing or planned void (where appropriate) using computer-aided design technology for anatomy enhancement, correction of trauma injuries, and/or to correct congenital defects in the craniofacial bone.
| Study group | Role | What they receive |
|---|---|---|
| Facial Plating | Patients undergoing surgical procedures for facial reconstruction for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair. Receives: Device: Titanium Facial Plates | |
| Mandibular Plating | Patients undergoing surgical procedures for mandibular reconstruction, including TMJ, for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair. Receives: Device: Titanium Mandibular Plates; Device: Add-on Condyle | |
| HTR-PEKK (midface) | Patients undergoing surgical procedures for midface reconstruction using custom-made prostheses manufactured on PEEK material. Receives: Device: HTR-PEKK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of implant at 1 year post operative
Frequency and incidence of clinical and radiological adverse events related to the implantation of the subject device leading to removal
Measured: 1 year
Secondary outcomes (2)
Infection rate at 30 days post operative
Implant site infection rate
Measured: 30 days
Allergic reaction related to implant material
Clinical and/or pathological assessment of implant allergic reactions leading to removal of the device in the first 2 years post implantation
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Oct 2021
- Primary completion1 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Sun, PhD, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931056
- Sponsor's protocol ID
- 0220-02
- Status last verified
- Jan 2024
- First submitted
- 19 May 2021
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This data will support regulatory approval on the subject device. Data from this study will not be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Biomet Microfixation Devices Used in Facial & Mandibular Surgical Procedures. Facial Plating System, HTR PEKK (Midface) and Mandibular Plates: A Post Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT04931056
- Acronym / sponsor ID
- 0220-02
- Conditions
- Tumor, Facial Fracture, Mandibular Fractures, Fibrous Dysplasia, Osteoma of Mandibular Condyle, Neuroma
- Keywords
- facial plates, mandibular reconstruction, facial reconstruction, condylar tumor, orofacial cleft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Jun 2021 (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.
This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.
Detailed description
The subject devices are:
- plates, screws, and primary instruments from the Biomet Microfixation Facial Plating System, including plates to be specifically used in orthognathic procedures
- plates, screws and primary instruments for the Mandibular Plating System, including and a device intended to temporarily restore the functionality of the temporomandibular joint for patients whose natural condyle has to be resected, subsequent to a tumor ablation ("Add-On Condyle") Additionally, a third device intended for the replacement of bony voids in the facial skeleton will be evaluated in this trial (HTR-PEKK- facial application).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Facial Plating | – | Device: Titanium Facial PlatesPatients undergoing surgical procedures for facial reconstruction for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair. |
| Mandibular Plating | – | Device: Titanium Mandibular Plates, Device: Add-on CondylePatients undergoing surgical procedures for mandibular reconstruction, including TMJ, for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair. |
| HTR-PEKK (midface) | – | Device: HTR-PEKKPatients undergoing surgical procedures for midface reconstruction using custom-made prostheses manufactured on PEEK material. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects, who underwent a facial, orbital, or midface procedure and received plates, screws and/or mesh manufactured by Biomet Microfixation. All enrolled subjects will provide data from a retrospective chart review on outcomes of interest.
Key inclusion criteria (7 listed)
- Males or females
- A patient who underwent one or more of the following surgical procedures completed between January 1, 2015 and December 31, 2019, with plates, screws, and or meshes from the Biomet Microfixation Facial Plating System:
- Available follow-up data at least at 30 days' post-operative
Key exclusion criteria (4 listed)
- Active or latent infection at the time of implantation
- Documented foreign body sensitivity
- Patients with limited blood supply, insufficient quantity or quality of bone (e.g., osteomalacia or a bone resorption condition such as Paget's disease, osteoporosis, bone metastasis)
- Patients with documented mental or neurologic conditions who were unwilling or incapable of following postoperative care instructions
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 |
|---|---|---|
| Titanium Facial PlatesAlso: Titanium facial mini platesThe Facial Plating System provides a comprehensive titanium fixation solution for maxillofacial surgery procedures. More than twenty-five different plating options in two systems, the 1.5 mm and 2.0 mm with a variety of instruments, and high torque screws, including meshes, are part of this system. Plates and screws are made of commercially pure titanium per ASTM F-67, Titanium 6Al 4V Alloy per ASTM F-136. | Device | Facial Plating |
| Titanium Mandibular PlatesAlso: Titanium mandibular mini platesThe Mandibular Plating System provides a comprehensive titanium fixation solution for mandibular surgical procedures. Several plating options, a variety of instruments, and high torque screws with various plate shapes are part of this system. Plates in the Mandibular Plating System have profiles of various thicknesses. Screws are available in self-tapping, locking and non-locking varieties, and in various sizes between 2.0 mm and 2.3 mm in diameter, and 5 mm to 18 mm in length. | Device | Mandibular Plating |
| Add-on CondyleThe Add-On Condyle is intended to be implanted in the human jaw to replace the mandibular condyle to functionally reconstruct the temporomandibular joint on a temporary basis for patients undergoing ablative tumor surgery requiring the removal of the native mandibular condyle. This device is not for permanent implantation, traumatic injuries, or for treatment of temporomandibular joint disease. | Device | Mandibular Plating |
| HTR-PEKKThe HTR-PEKK implants are fabricated from polyether-ketone-ketone (PEKK) via selective laser sintering (SLS), a 3D manufacturing technique. The laser sintering machine builds the implant in layers as dictated from a stereolithographic (STL) file of the approved implant. The HTR-PEKK implants are designed individually for each patient to replace bony voids in the facial anatomy using a patient's own CT imaging data. The implant is made to fill an existing or planned void (where appropriate) using computer-aided design technology for anatomy enhancement, correction of trauma injuries, and/or to correct congenital defects in the craniofacial bone. | Device | HTR-PEKK (midface) |
Primary outcome
Survival of implant at 1 year post operative
Time frame: 1 year
Frequency and incidence of clinical and radiological adverse events related to the implantation of the subject device leading to removal
2 secondary outcomes
Infection rate at 30 days post operative
Time frame: 30 days
Allergic reaction related to implant material
Time frame: up to 2 years
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 29 Jan 2024.
- Individual participant dataSharing planned: No. This data will support regulatory approval on the subject device. Data from this study will not be made available to other researchers
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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.
Mark Sun, PhD study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor and Facial Fracture, run by Zimmer Biomet at 1 site in Argentina.
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 7 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 29 Jan 2024. 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 Argentina. 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?
Survival of implant at 1 year post operative (time frame: 1 year). 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 29 Jan 2024.