Quality of Life in Patients With Traumatic Rib Fracture After Rib Fracture Surgery (NCT03487458) | Clinical Trial Compass
UnknownNot Applicable
Quality of Life in Patients With Traumatic Rib Fracture After Rib Fracture Surgery
Taiwan50 participantsStarted 2017-06-13
Plain-language summary
This study is a prospective study. Patients with traumatic rib fractures are divided into control group and surgical (OP) group, depending on whether they undergo rib fracture fixation surgeries. They complete Short Form-36 and Work Quality Index (WQI) before surgery and after surgery (before discharge, post-surgery 1 month, 3 months and 6 months). The goal of this study is to examine the life quality of patients who receive surgical treatment for rib fracture by analyzing patients' response, comorbidity, vital signs (blood pressure, heart rate, respiratory rate, Glasgow Coma Scale (GCS) etc.), severity of fracture (AIS, ISS) and medical costs. The investigators hope to find the most suitable method of treatment for patients with rib fractures.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Flail chest with paradoxical respiration
. Multiple rib fractures with uncontrolled hemothorax or pneumothorax
. Severe thoracic trauma causing respiratory failure (ex poor blood oxygen saturation, hypercapnia, overtime intubation etc.)
. Fractures of 3 or more ribs, with moderate amount of hemothorax or pneumothorax
. Fractures of 3 or more ribs, with clavicle or scapula fractures, requiring surgical intervention
. Fractures of 3 or more ribs, with obvious rib displacement and pain
. Chronic neuropathic pain, with poor drug control
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Short Form-36 (SF-36)
Timeframe: Assessment of change in SF-36 scores for the control group at admission and after discharge for up to six months and for the surgical group before and after surgery for up to 6 months.
. Symptoms due to poor healing of fracture site (ex. dyspnea or restrictive lung disease)
Exclusion criteria
. High risk for surgery (ex. Age greater than 75 y/o, poor cardiopulmonary function, abnormal coagulation, end-stage renal disease, hepatic failure etc.)
. Severe chest trauma, with large area of lung contusion or pulmonary embolism
. More than 2 organs of systemic severe trauma (ex. combining head trauma, abdominal internal bleeding, abdominal organ rupture etc.)