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
Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
View:
• Males or females
• 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
• Available follow-up data at least at 30 days' post-operative
Locations
Other Locations
Argentina
San Bernardo Hospital
Salta
Time Frame
Start Date: 2021-10-01
Completion Date: 2023-11-30
Participants
Target number of participants: 91
Treatments
Facial Plating
Patients undergoing surgical procedures for facial reconstruction for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair.
Mandibular Plating
Patients undergoing surgical procedures for mandibular reconstruction, including TMJ, for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair.
HTR-PEKK (midface)
Patients undergoing surgical procedures for midface reconstruction using custom-made prostheses manufactured on PEEK material.
Authors
Gonzalo A Herrera
Related Therapeutic Areas
Sponsors
Leads: Zimmer Biomet