Recruiting

RibFix Titan

Sponsor:

Zimmer Biomet

Code:

NCT07485829

Conditions

Rib Fracture

Rib Fracture Multiple

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

The RibFix Titan™ device should be used within this arm of the study.

Study Details

Brief 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.

Conditions

Rib Fracture

Rib Fracture Multiple

Study ID

NCT07485829

Start date

Mar 31, 2026

Status verified date

Apr, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Interventions and Outcome Measures

Arms

Rib Fixation

Consecutive patients will undergo rib fixation procedure using the RibFix Titan fixation system.

Interventions

The RibFix Titan™ device should be used within this arm of the study.

Rib Fixation

Primary outcome measure

  • Evaluation of Patient Safety [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Megan McKinnie

(919)381-7091megan.mckinnie@zimmerbiomet.com

Lynsey Boyle

(412)552-7111

Locations

Ascension St. Vincent Hospital

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Jamie Williams

317-210-3487jamie.williams4@ascension.org

Principal Investigator:

Nakul Valsangkar, MD

More Information

Sponsor

Zimmer Biomet

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • RibFix Titan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zimmer Biomet on 2026-04-21.