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Clinical Trials in the USA / NCT07485829
Recruiting Observational

Zimmer Biomet-RibFix Titan

NCT07485829 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Observational
Started
2026-03-31
Last updated
2026-04-21

Condition(s) studied

Rib FractureRib Fracture Multiple

Investigational drug(s) / intervention(s)

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

The RibFix Titan™ device should be used within this arm of the study.: Rib Fixation

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Evaluation of Patient Safety — 90 days
    Assessment of safety by analyzing reoperation rates related to the RibFix Titan™ at 90 days post-implantation. A reoperation will be considered any additional surgical procedure to revise, adjust, or replace the subject device's components and/or any surgical procedure to manage complications directly caused by the device.

Trial sites (1)

FacilityCityRegionStatus
Ascension St. Vincent Hospital Indianapolis Indiana Recruiting

More Zimmer Biomet trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07485829 on ClinicalTrials.gov ↗ ← All trials in the USA