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

Zimmer Biomet

Status: Completed

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

Treatments: Device: Titanium Facial Plates; Device: Add-on Condyle; Device: HTR-PEKK; Device: Titanium Mandibular Plates

Study type: Observational

Funder types: Industry

Identifiers

NCT04931056

0220-02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 91 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

91 participants in 3 patient groups

Facial Plating

Description:

Patients undergoing surgical procedures for facial reconstruction for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair.

Treatment:

Device: Titanium Facial Plates

Mandibular Plating

Description:

Patients undergoing surgical procedures for mandibular reconstruction, including TMJ, for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair.

Treatment:

Device: Titanium Mandibular Plates

Device: Add-on Condyle

HTR-PEKK (midface)

Description:

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

Treatment:

Device: HTR-PEKK