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Completed

NCT Number: NCT04931056

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

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.

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Key information

Conditions

Tumor Acrofacial dysostosis, Nager type Bone Diseases Bone Diseases, Developmental Cleft Face Coloboma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Craniofacial Abnormalities Craniofacial Dysostosis Dysostoses Eye Diseases Eye Diseases, Hereditary Facial Fracture Facial Injuries Fibrous Dysplasia Fibrous Dysplasia of Bone Fractures, Bone Genee-Wiedemann syndrome Goldenhar Syndrome Hemifacial Microsomia Jaw Fractures Mandibular Fractures Mandibulofacial Dysostosis Maxillofacial Injuries Miller Syndrome Musculoskeletal Abnormalities Musculoskeletal Diseases Nager Syndrome Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Nervous System Diseases Neuroma Osteochondrodysplasias Osteoma of Mandibular Condyle Skull Fractures Trauma, Nervous System Treacher Collins Syndrome Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Bernardo Hospital

Salta, Argentina

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Titanium facial mini plates

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.

Other names: Titanium mandibular mini plates

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Infection rate at 30 days post operative

    Time frame: 30 days

    Implant site infection rate

  2. Allergic reaction related to implant material

    Time frame: up to 2 years

    Clinical and/or pathological assessment of implant allergic reactions leading to removal of the device in the first 2 years post implantation

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2021
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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