Tumor Clinical Trial
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
NCT number | NCT04931056 |
Other study ID # | 0220-02 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2021 |
Est. completion date | November 30, 2023 |
Verified date | January 2024 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 91 |
Est. completion date | November 30, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Argentina | San Bernardo Hospital | Salta |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival of implant at 1 year post operative | Frequency and incidence of clinical and radiological adverse events related to the implantation of the subject device leading to removal | 1 year | |
Secondary | Infection rate at 30 days post operative | Implant site infection rate | 30 days | |
Secondary | Allergic reaction related to implant material | Clinical and/or pathological assessment of implant allergic reactions leading to removal of the device in the first 2 years post implantation | up to 2 years |
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