Clinical trial NCT04931056: A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-06-18
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Survival of implant at 1 year post operative
timeFrame: 1 year
Secondary outcomes:
measure: Infection rate at 30 days post operative
timeFrame: 30 days
measure: Allergic reaction related to implant material
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Salta
country: Argentina
facility: San Bernardo Hospital
Study officials:
affiliation: Zimmer Biomet
name: Mark Sun, PhD
role: STUDY_DIRECTOR
References: