RibFix Titan implants for stabilizing rib fractures
Official title: Zimmer Biomet Patient Outcomes and Experience After Chest Wall Repair With RibFix Titan™
Run by Zimmer Biomet · NCT07485829 · Data updated 2026-11-12
This follow-up will see if using the RibFix Titan implant is safe and helps adults with single or multiple rib fractures recover after surgical fixation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | March 31, 2026 |
| Main results expected | July 2027 |
| Study ends | March 2028 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07485829 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) who are candidates for surgical fixation, stabilization, or fusion of rib fractures or osteotomies, can give informed consent, and are able to follow post-operative care instructions are ideal candidates.
✕Probably not a fit
Patients with active infections, suspected material sensitivity without prior testing, inability to adhere to post-operative care, recent midline sternotomy crossing the midline, or those not expected to survive the follow-up period are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center, non-randomized, single-cohort post-market follow-up of the RibFix Titan system used for fusion, stabilization, and fixation of rib fractures and planned osteotomies. Consecutive eligible adults who undergo implantation will be enrolled and followed at pre-op, operative, 14 days, 45 days, 90 days, and 1 year post-operatively. The primary outcome is device-related safety measured by reoperation rates at 90 days, with secondary outcomes including fracture/osteotomy union, patient-reported outcomes, and measures of resource use such as ICU and hospital length of stay and operative time. Adverse events and their relationship to the implant, instrumentation, and procedure will be recorded throughout the operative and postoperative periods.
Why it matters
Potential benefit: If successful, this could lower device-related reoperations and improve healing, pain, and recovery time for patients needing rib fixation.
How similar studies have gone: Previous clinical reports and trials of rib plating systems, including earlier RibFix devices, have shown improved chest-wall stability and symptom relief in select trauma patients, although large randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion 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, 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
Where it's running
-
Ascension St. Vincent Hospital
Indianapolis, Indiana, United States Recruiting
Study contacts
- Study coordinator: Megan McKinnie
- Email: megan.mckinnie@zimmerbiomet.com
- Phone: (919)381-7091
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.