Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT04931056
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
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04931056
Study Brief:
Protocol Section:
NCT04931056