RibFix Titan implants for stabilizing rib fractures

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

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
• Enrollment: 54 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zimmer Biomet (industry)
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT07485829 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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, 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 this trial is running

Indianapolis, Indiana

• Ascension St. Vincent Hospital — Indianapolis, Indiana, United States (RECRUITING)

Study contacts

• Study coordinator: Megan McKinnie

Conditions: Rib Fracture, Rib Fracture Multiple, RibFix Titan