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

NCT04931056 | Completed FDA Device

• 1 other identifier: 0220-02
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor; Facial Fracture; Mandibular Fractures; Fibrous Dysplasia; Osteoma of Mandibular Condyle; Neuroma; Cleft Face; Hemifacial Microsomia; Treacher Collins Syndrome; Miller Syndrome; Nager Syndrome

Keywords

facial plates; mandibular reconstruction; facial reconstruction; condylar tumor; orofacial cleft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Infection rate at 30 days post operative

  30 days

• Allergic reaction related to implant material

  up to 2 years

Study Arms (3)

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

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; Device: Add-on Condyle

HTR-PEKK (midface)

Patients undergoing surgical procedures for midface reconstruction using custom-made prostheses manufactured on PEEK material.

Device: HTR-PEKK

Interventions

Titanium Facial Plates DEVICE

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.

Also known as: Titanium facial mini plates

Facial Plating

Titanium Mandibular Plates DEVICE

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.

Also known as: Titanium mandibular mini plates

Mandibular Plating

Add-on Condyle DEVICE

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.

Mandibular Plating

HTR-PEKK DEVICE

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.

HTR-PEKK (midface)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

San Bernardo Hospital

Salta, Argentina

Location

MeSH Terms

Conditions

Neoplasms; Mandibular Fractures; Fibrous Dysplasia of Bone; Neuroma; Goldenhar Syndrome; Mandibulofacial Dysostosis; Genee-Wiedemann syndrome; Acrofacial dysostosis, Nager type

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Craniofacial Dysostosis; Dysostoses; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Coloboma; Eye Diseases, Hereditary; Eye Diseases

Study Officials

• Mark Sun, PhD

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 18, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: November 30, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)