CompletedNot Applicable

A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.

Argentina91 participantsStarted 2021-10-01

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. 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:
✓. Available follow-up data at least at 30 days' post-operative

Exclusion criteria

✕. Active or latent infection at the time of implantation
✕. Documented foreign body sensitivity
✕. 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)
✕. Patients with documented mental or neurologic conditions who were unwilling or incapable of following postoperative care instructions

What they're measuring

Survival of implant at 1 year post operative

Timeframe: 1 year

Trial details

NCT IDNCT04931056

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-09-01

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