No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
54 (estimated)
Sponsor
Zimmer Biomet · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
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, stabilizati…
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
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