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

Completed

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

• Registration Number: NCT04931056
• Lead Sponsor: Zimmer Biomet

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.

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).

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-18
• Study Start: 2021-10-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival of implant at 1 year post operative	1 year	Frequency and incidence of clinical and radiological adverse events related to the implantation of the subject device leading to removal

Secondary Outcome Measures

Name	Time	Method
Infection rate at 30 days post operative	30 days	Implant site infection rate
Allergic reaction related to implant material	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

Trial Locations

Locations (1)

San Bernardo Hospital; 🇦🇷 Salta, Argentina