Multicenter RCT of SSRF in Non Flail Patients
Completed · Not applicable
Conditions studied: Rib Fracture Multiple
In brief
This study evaluates the efficacy of surgical stabilization of rib fractures, as compared to best medical management, for patients with multiple, displaced rib fractures. Half of patients will be randomized to surgery (in addition to best medical management), whereas the other half will be randomized to medical therapy only. The primary outcome will be the subjects overall quality of life measured at two months following injury.
Key facts
- Study ID
- NCT03221595
- Run by
- Denver Health and Hospital Authority
- People needed
- 110
- Starts
- 2018-01-02
- Expected to finish
- 2020-01-01
- Last updated by the study team
- 2021-05-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Hospitalization with ≥ 3 severely displaced (≥ 50% of rib width) acute rib fractures.
- Two or more of the following pulmonary physiologic derangements (at the time of consideration for enrollment and after best medical therapy).
- Respiratory rate > 20 breaths per minute
- Incentive spirometry < 50% predicted (appendix D)
- Numeric pain score > 5
- Poor cough (as documented by respiratory therapist)
- Surgery anticipated < 72 hours from injury
You may not qualify if…
- Age < 18 years or ≥ 80 years
- Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.
- Moderate or severe traumatic brain injury (GCS at the time of consideration for enrollment < 12)
- Intubation
- Severe pulmonary contusion, defined as Blunt Pulmonary Contusion 18 (BPC18) score > 12 [19].
- Prior or expected emergency exploratory laparotomy during this admission.
- Prior or expected emergency thoracotomy during this admission.
- Prior or expected emergency craniotomy during this admission.
- Spinal cord injury
- Pelvic fracture that has required, or is expected to require, operative intervention during this admission.
- The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, prepearing meals).
- Pregnancy.
- Incarceration.
Where it is running
- Denver Health Medical Center — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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