NCT04931056

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: —

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.

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
• Cleft Face
• Hemifacial Microsomia
• Treacher Collins Syndrome
• Miller Syndrome
• Nager Syndrome

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-09-01
• Completion: 2023-11-30
• First posted: 2021-06-18
• Last updated: 2024-01-29

Locations

1 site across 1 country: Argentina

Regulatory

• FDA-regulated device study