Zimmer Biomet Patient Outcomes and Experience After Chest Wall Repair With RibFix Titan™
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Evaluation of Patient Safety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Rib Fixation
Consecutive patients will undergo rib fixation procedure using the RibFix Titan fixation system.
干预措施: The RibFix Titan™ device should be used within this arm of the study. (Device)
结局指标
主要结局
Evaluation of Patient Safety
时间窗: 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.
次要结局
- 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)