Zimmer Biomet Patient Outcomes and Experience After Chest Wall Repair With RibFix Titan™
Zimmer Biomet
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.
Description
Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process. The primary objective is the 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. This study is designed t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 sensitivi…
Interventions
- DeviceThe RibFix Titan™ device should be used within this arm of the study.
Rib Fixation
Location
- Ascension St. Vincent HospitalIndianapolis, Indiana