Rib Fracture, Rib Fracture Multiple
Conditions
Keywords
RibFix Titan
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.
Detailed description
Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process. The primary objective is the 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. This study is designed to evaluate safety parameters by recording the incidence and frequency of complications and adverse events. Relationship of the events to the implant, instrumentation, and/or procedure through the operative and post-operative follow-up periods shall be specified. The secondary objectives include functional performance and clinical benefits by clinical evaluation of fracture/osteotomy union and patient reported outcome measures (PROMs). This study will also measure resource utilization in subjects with RibFix Titan™, including intensive care unit (ICU) length of stay, hospital length of stay, and operative time. Data collection will occur at the following intervals: Pre-operative, Operative, 14-days, 45-days, 90-days, and 1-year post-operatively. Enrollment for the study is anticipated to last approximately 12 months. Allowing for 12 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 24 months.
Interventions
DEVICEThe RibFix Titan™ device should be used within this arm of the study.
Rib Fixation
Sponsors
Zimmer Biomet
Riverpoint Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Patient Safety | 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Measure (PROMIS-Pain Interference 8a) | 12 Months | 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. |
| Patient Reported Outcome Measure (PROMIS-Physical Function 10b) | 12 Months | 10-item questionnaire, answered by the patient, with questions asking the patient to rate their level of difficulty performing physical activities. |
| Patient Reported Outcome Measure (Numeric Pain Rating Scale) | 12 Months | 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. |
Countries
United States
Contacts
CONTACTMegan McKinnie
CONTACTLynsey Boyle
STUDY_DIRECTORHillary Overholser
Zimmer Biomet
Outcome results
None listed