Zimmer Biomet-RibFix Titan
Recruiting now
Conditions studied: Rib Fracture, Rib Fracture Multiple
In brief
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.
Key facts
- Study ID
- NCT07485829
- Run by
- Zimmer Biomet
- People needed
- 54
- Starts
- 2026-03-31
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-04-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 18 years of age
- 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
- 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
You may not qualify if…
- Midline Sternotomy: sternotomy incisions crossing the midline
- Active Infection: patients should not have any ongoing infections
- Material Sensitivity: where sensitivity to materials is suspected, comprehensive testing should be conducted before implantation
- 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
- Patients not expected to survive the duration of follow-up due to the involvement of trauma situations
- Patients with a history of alcohol or substance abuse, as well as vulnerable populations such as prisoners and pregnant women
Where it is running
- Ascension St. Vincent Hospital — Indianapolis, Indiana, United States (enrolling)
Full record on ClinicalTrials.gov
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