Zimmer Biomet-RibFix Titan

NCT07485829 | Recruiting FDA Device

• 1 other identifier: CSE2023-20T
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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

Keywords

RibFix Titan

Outcome Measures

Primary Outcomes (1)

• Evaluation of Patient Safety

  Assessment of safety by analyzing reoperation rates related to the RibFix Titan™ at 90 days post-implantation. A reoperation will be considered any additional surgical procedure to revise, adjust, or replace the subject device's components and/or any surgical procedure to manage complications directly caused by the device.

  90 days

Secondary Outcomes (3)

• Patient Reported Outcome Measure (PROMIS-Pain Interference 8a)

  12 Months

• Patient Reported Outcome Measure (PROMIS-Physical Function 10b)

  12 Months

• Patient Reported Outcome Measure (Numeric Pain Rating Scale)

  12 Months

Study Arms (1)

Rib Fixation

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

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

Interventions

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

Rib Fixation

Rib Fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include subjects with rib fractures identified at the point of clinical presentation, including emergency departments, trauma centers, or outpatient healthcare settings.

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients not expected to survive the duration of follow-up due to the involvement of trauma situations
• Patients with a history of alcohol or substance abuse, as well as vulnerable populations such as prisoners and pregnant women

Sponsors & Collaborators

• Zimmer Biomet: lead
• Riverpoint Medical: collaborator

Study Sites (1)

Ascension St. Vincent Hospital

Indianapolis, Indiana, 46260, United States

RECRUITING

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Megan McKinnie

CONTACT

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

Lynsey Boyle

CONTACT

(412)552-7111

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)