Impact of Time Interval Between Trauma and Operation on Clinical Outcome in Patients With Delayed Rib Fixation (Nonunion)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Recommendation of the surgery to another person in a situation like the own
研究概览
简要总结
The goal of this monocentric observational study is to evaluate the outcomes of patients who underwent a delayed surgical stabilization of rib fractures/surgical stabilization of rib fracture nonunion (SSRFN) based on the timing of surgery after trauma.
详细描述
Rib fractures occur in a significant number of patients with blunt chest trauma, and while conservative treatment remains the standard, surgical stabilization of rib fractures (SSRF) has shown improved clinical outcomes. However, conservative therapy often results in chronic chest pain and long-term incapacity, with up to 64% of patients experiencing persistent pain. Additionally, rib fracture nonunion, a condition where the bone fails to heal, affects approximately 12-15% of cases treated conservatively and can lead to long-term complications, including pain, limited mobility, and impaired quality of life.
This single-center observational study aims to analyze the outcomes of patients who underwent delayed SSRF (surgery between 3 weeks and 3 months after trauma) or nonunion SSRF (surgery performed more than 3 months after trauma). To assess whether a shorter interval between trauma and surgery results in better outcomes, the primary objective is to assess the persistence of thoracic pain in both patient groups. The secondary objective is to determine if SSRF improved patients' well-being.
This prospective research project is a single center analysis of existing data on patients, who underwent rib fixation for nonunion at the Department of Thoracic Surgery of the University Hospital Basel between January 1st, 2012 and June 30th, 2024. A prospective follow-up visit will be organized to assess the postoperative outcome.
The results of this study will provide valuable insights into optimizing treatment timelines for non consolidated rib fractures or rib fracture nonunion, improving patient outcomes and reducing long-term pain and disability.
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
- •Patients who signed the study specific consent form
- •Patients aged ≥18 years at the time of informed consent
- •Patients who provided written informed consent in accordance with ICH-GCP regulations prior to participating any protocol-specific follow-up
- •Patients with at least one rib fracture caused by trauma (traffic accident, falls), surgery (cardiac, thoracic, lung transplantation), sports, cough, and cardiopulmonary resuscitation
排除标准
- •Patients who were treated conservatively
- •Patients who underwent rib fixation till 3 weeks after trauma
- •Patients who underwent SSRF prior to SSRFN
- •Patients who are unable to follow the procedures of the study, e. g. have insufficient knowledge of German or French languages, psychological disorders, dementia etc.
- •Patients with a pathological rib fracture(s) due to malignancy or radiation
- •Participation in any interventional study in our department that might influence any of the outcome parameters
- •Patients who underwent an initial surgery of rib fracture prior to development of a rib fracture nonunion
结局指标
主要结局
Recommendation of the surgery to another person in a situation like the own
时间窗: After surgery at follow-up visit (1-8 weeks after recruitment)
The patients will be asked if they would recommend the surgery to another person in a situation like the own. The assessment will be performed in two categories: yes/no.
Pain status at Follow-up (FU)
时间窗: After surgery at follow-up visit (1-8 weeks after recruitment)
The pain status at the timepoint of the follow-up visit is measured using the numeric rating scale (NRS, scale 0: no pain to 10: worst pain) in different situations (at rest, at movement, and during deep inspiration). The type of pain (local, diffuse, neurogenic) will be also assessed.
Pain status at FU compared to before surgery
时间窗: After surgery at follow-up visit (1-8 weeks after recruitment)
The pain status at the timepoint of the follow-up visit compared to the timepoint before surgery in five distinct categories on a Likert-scale (much better, slightly better, no change, slightly worse, much worse).
Painkiller Use (including nonsteroidal anti-inflammatory drugs and opioids)
时间窗: After surgery at follow-up visit (1-8 weeks after recruitment)
The painkiller use including nonsteroidal anti-inflammatory drugs and opioids is being recorded.
次要结局
- Health status(After surgery at follow-up visit (1-8 weeks after recruitment))
- Resumption of daily/professional activity at FU(After surgery at follow-up visit (1-8 weeks after recruitment))
- Resumption of daily/professional activity at FU compared to before surgery(After surgery at follow-up visit (1-8 weeks after recruitment))
- Complications(Day 30 after surgery)
- Correlation between Number of Broken Ribs, Fixed Ribs, and Impact on Patient Outcomes(After surgery at follow-up visit (1-8 weeks after recruitment))
- Association between Age and clinical outcomes(After surgery at follow-up visit (1-8 weeks after recruitment))
- Impact of Gender and Clinical Outcomes(After surgery at follow-up visit (1-8 weeks after recruitment))
- Frequency of Risk Factors for Rib Fracture Nonunion(After surgery at follow-up visit (1-8 weeks after recruitment))
- Impact of Rib Fracture Localization on Clinical Outcomes(After surgery at follow-up visit (1-8 weeks after recruitment))
- Physical examination(After surgery at follow-up visit (1-8 weeks after recruitment))