A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.

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.

Study Overview

• Status: Completed
• Conditions: Tumor; Neuroma; Mandibular Fractures; Treacher Collins Syndrome; Facial Fracture; Fibrous Dysplasia; Hemifacial Microsomia; Miller Syndrome; Osteoma of Mandibular Condyle; Cleft Face; Nager Syndrome
• Intervention / Treatment: Device: Titanium Facial Plates; Device: Titanium Mandibular Plates; Device: Add-on Condyle; Device: HTR-PEKK

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 Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

• Study Contact: Name: Oscar Gonzalez, MD, DNP; Phone Number: 9277 9047414400; Email: oscar.gonzalezmonteagudo@zimmerbiomet.com
• Study Contact Backup: Name: Eric W Bast, JD; Phone Number: 8541 904-741-4400; Email: eric.bast@zimmerbiomet.com

Study Locations

• Argentina
  • Salta, Argentina
    • San Bernardo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Males or females

2. 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
3. Available follow-up data at least at 30 days' post-operative

Exclusion Criteria:

1. Active or latent infection at the time of implantation
2. Documented foreign body sensitivity
3. 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)
4. Patients with documented mental or neurologic conditions who were unwilling or incapable of following postoperative care instructions

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Facial Plating; Patients undergoing surgical procedures for facial reconstruction for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair.	Device: Titanium Facial 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.; Other Names: Titanium facial mini 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.	Device: Titanium Mandibular 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.; Other Names: Titanium mandibular mini plates; Device: Add-on Condyle; 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-PEKK (midface); Patients undergoing surgical procedures for midface reconstruction using custom-made prostheses manufactured on PEEK material.	Device: HTR-PEKK; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection rate at 30 days post operative	Implant site infection rate	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	up to 2 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Mark Sun, PhD, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: facial reconstruction; mandibular reconstruction; facial plates; condylar tumor; orofacial cleft
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Eye Diseases; Wounds and Injuries; Disease Attributes; Disease; Congenital Abnormalities; Musculoskeletal Diseases; Neoplasms, Nerve Tissue; Craniocerebral Trauma; Trauma, Nervous System; Eye Diseases, Hereditary; Bone Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Nerve Sheath Neoplasms; Osteochondrodysplasias; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Craniofacial Dysostosis; Dysostoses; Coloboma; Syndrome; Fractures, Bone; Osteoma; Neuroma; Mandibular Fractures; Goldenhar Syndrome; Facies; Fibrous Dysplasia of Bone; Mandibulofacial Dysostosis
• Other Study ID Numbers: 0220-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This data will support regulatory approval on the subject device. Data from this study will not be made available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes