TerminatedNot Applicable

Randomized Clinical Trial of Rib Fixation Versus Medical Analgesia in Uncomplicated Rib Fractures on Pain Control.

Stopped: Participant recruitment was too low. One of the reasons is the overly strict exclusion criteria.

Switzerland102 participantsStarted 2021-03-12

Plain-language summary

Uncomplicated costal fractures often result in persistent pain over the long term. Indeed, cohort studies showed that at 6 months, 22% of patients still had pain and 56% had functional disability. The impact of costal fractures on quality of life is underestimated. The socio-psycho-economic consequences are substantial. Previous studies have shown that an important factor for persistent pain and functional disability is the intensity of the initial pain. However, preliminary studies have shown promising results with surgical fixation of rib fractures: reduced need for analgesic drugs, reduced pain at 1 month, reduced complications and improved motor skills in patients over 65 years of age. To date, the only clinical trials that exist focused on the fixation of complicated rib dislocations. While fixation of uncomplicated rib fractures is a common practice, no randomized studies have been conducted to evaluate its impact on pain and quality of life in the medium and long term. In this context, the aim of our randomized study is to compare pain at 2 months between operated and non-operated patients with uncomplicated rib fractures.

Who can participate

Age range

18 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: * At least 2 rib fractures * At least 1 dislocated rib fracture * Fractures accessible to surgery * Thoracic trauma no more than two days prior to screening for inclusion * Thoracic epidural analgesia * Written informed consent Exclusion Criteria: * Any other concomitant fractures excepted clavicle fracture * Respiratory distress syndrome according to the Berlin definition * Presence of \>1.5 liter of blood drained from the pleural space * Hemostasis disorder defined by any of the following criteria: * Platelet count \< 70'000/mm3, * International Normalized Ratio (INR) \> 1.2 (Prothrombin \< 70%) * activated partial thromboplastin time (aPTT) ≥ 60 seconds * drugs such as: P2Y12 antagonists (clopidogrel, prasugrel) and glycoprotein IIb/IIIa antagonists (abciximab, tirofiban) * Pathological rib fracture due to metastasis * Hemodynamic instability: systolic blood pressure \< 100 mmHg and heart rate \> 100 beats per minute * Neurologic disorder: Glasgow Coma Score \< 13 in the initial 24 hours, or intracerebral, epidural, subdural, or subarachnoid hemorrhages, or cerebral contusion * Titanium allergy * Known or suspected non-compliance to medical therapy due to drug or alcohol abuse * Age \<18 years old * Women who know they are pregnant or breast feeding * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

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

Pain severity

Timeframe: Two months after injury

Trial details

NCT IDNCT04745520

SponsorBenoît Bédat

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-16

View on ClinicalTrials.gov More Rib Fractures trials