Health TrialsbyHealthPanel

Zimmer Biomet-RibFix Titan

ConditionsRib FractureRib Fracture Multiple
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Device

    Rib Fixation

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Rib Fixation1 intervention

Trial outcomes

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.

Time frame
90 days

Secondary outcomes

1

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

8-item questionnaire, completed by the patient, with questions asking the patient to rate how much pain has impacted daily functioning over the past 7 days.

Time frame
12 Months
2

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

10-item questionnaire, answered by the patient, with questions asking the patient to rate their level of difficulty performing physical activities.

Time frame
12 Months
3

Patient Reported Outcome Measure (Numeric Pain Rating Scale)

1-item questionnaire asking the patient to rate their pain on average on a numeric scale, from 0 to 10 where 0 is No Pain and 10 is Worst Imaginable Pain.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zimmer Biomet

Lead sponsor

Riverpoint Medical

Collaborator

Source ClinicalTrials.gov
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