Clinical trial · Observational
A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.
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
NCT04931056CI-TRIAL-00073363completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cleft Face | — | UNRESOLVED | — |
| Facial Fracture | — | UNRESOLVED | — |
| Fibrous Dysplasia | Fibrous Dysplasia | ONTOLOGY_EXACT | 0.98 |
| Hemifacial Microsomia | — | UNRESOLVED | — |
| Mandibular Fractures | — | UNRESOLVED | — |
| Miller Syndrome | — | UNRESOLVED | — |
| Nager Syndrome | — | UNRESOLVED | — |
| Neuroma | — | UNRESOLVED | — |
| Osteoma of Mandibular Condyle | — | UNRESOLVED | — |
| Treacher Collins Syndrome | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Add-on Condyle | Device | — | UNRESOLVED |
| HTR-PEKK | Device | — | UNRESOLVED |
| Titanium Facial Plates | Device | — | UNRESOLVED |
| Titanium Mandibular Plates | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 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.
- interventionNames
- Device: Titanium Facial Plates
- label
- 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.
- interventionNames
- Device: Titanium Mandibular Plates
- Device: Add-on Condyle
- label
- HTR-PEKK (midface)
- description
- Patients undergoing surgical procedures for midface reconstruction using custom-made prostheses manufactured on PEEK material.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.