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Zimmer Biomet-RibFix Titan

Recruitingn/aAges 18 Years - anyAllZimmer Biomet
NCT07485829 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Prospective, single-center, non-randomized, single-cohort, post-market clinical follow-up study to confirm the safety, performance, and clinical benefits for the use of the RibFix Titan™ system implants and instrumentation) in the fusion, stabilization, and fixation of fractures in the chest wall including rib reconstructive surgical procedures, trauma, or planned osteotomies.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. At least 18 years of age 2. Willing and able to sign an Institutional Review Board (IRB) approved Informed Consent Form and able to comply with study requirements, in the Investigator's opinion 3. Independent of study participation, patient qualifies for fixation, stabilization, and/or fusion of rib fractures or osteotomies of normal and osteoporotic bone with the study device Exclusion Criteria: 1. Midline Sternotomy: sternotomy incisions crossing the midline 2. Active Infection: patients should not have any ongoing infections 3. Material Sensitivity: where sensitivity to materials is suspected, comprehensive testing should be conducted before implantation 4. Inability to Adhere to Post-operative Care: Patients must have the ability and willingness to comply with post-operative care instructions, which may not be possible for individuals with certain mental or neurological conditions 5. Patients not expected to survive the duration of follow-up due to the involvement of trauma situations 6. Patients with a history of alcohol or substance abuse, as well as vulnerable populations such as prisoners and pregnant women
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What it tests

  • The RibFix Titan™ device should be used within this arm of the study.
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Where

1 site
Ascension St. Vincent Hospital
Indianapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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