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.
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.
Study Type
OBSERVATIONAL
Enrollment
54
Rib Fixation
Ascension St. Vincent Hospital
Indianapolis, Indiana, United States
RECRUITINGEvaluation 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
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
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
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
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