RecruitingNCT07485829

Zimmer Biomet-RibFix Titan

Zimmer Biomet Patient Outcomes and Experience After Chest Wall Repair With RibFix Titan™

Sponsor

Zimmer Biomet

Enrollment

54 participants

Start Date

Mar 31, 2026

Study Type

OBSERVATIONAL

Conditions

rib fracture Rib Fracture Multiple

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

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria6

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