N/A
Completed N=110
Multicenter RCT of SSRF in Non Flail Patients
Rib Fracture Multiple
Source: ClinicalTrials.gov NCT03221595 ↗
Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Numeric Pain Score — 7.5; 7; 6.3; 6.0 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Pain Score |
7.5; 7; 6.3; 6.0; 5.3; 5.9 | — |
| SECONDARY Length of Stay |
7; 6; 2; 2 | — |
| SECONDARY Daily Narcotic Use |
2.6; 1.6; 2.0; 2.0; 1.5; 1.6 | — |
| SECONDARY Incentive Spirometry |
39; 39.5; 40; 41.5; 46; 49 | — |
| SECONDARY Pulmonary Function Testing |
75.5; 75.8 | — |
| SECONDARY Number of Patients With Pneumonia |
1; 4 | — |
| SECONDARY Days of Ventilator-dependent Respiratory Failure |
0; 0 | — |
| SECONDARY Chest Wall Specific Quality of Life Questionnaire |
20.6; 25.3; 16.9; 22.4; 10.4; 15.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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 5
- Poor cough (as documented by respiratory therapist)
- Surgery anticipated 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.
Data sourced from ClinicalTrials.gov (NCT03221595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.