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

Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931056
• Other study ID #: 0220-02
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 30, 2023
• Est. primary completion date: September 1, 2023
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Fracture
• Facies
• Fibrous Dysplasia
• Fibrous Dysplasia of Bone
• Fractures, Bone
• Goldenhar Syndrome
• Hemifacial Microsomia
• Mandibular Fractures
• Neuroma
• Syndrome
• Tumor

Intervention

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.
• 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.
• 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
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.

Locations

Country	Name	City	State
Argentina	San Bernardo Hospital	Salta

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Infection rate at 30 days post operative	Implant site infection rate	30 days
Secondary	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