Zimmer Biomet-RibFix Titan
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- The RibFix Titan™ device should be used within this arm of the study.
Treatment groups
54 Participants
are divided into 1 treatment groupSponsors and collaborators
Zimmer Biomet
Lead sponsor
Riverpoint Medical
Collaborator
Source ClinicalTrials.gov