An interventional study of Operative in Rib Fracture Multiple, sponsored by Denver Health and Hospital Authority. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Denver Health and Hospital Authority · Not applicable, Interventional, and Other
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.
Rib fracture are the most common serious injury following blunt trauma, and occur in approximately 10% of trauma patients [1]. Despite improvements in the care of rib fracture patients, outcomes remain poor and have not changed substantially over the last 15 years [2]. Poor outcomes resulting from serious rib fractures include both acute complications (e.g., pneumonia, prolonged mechanical ventilation, and death) and chronic disability (e.g., pain, dyspnea, and loss of productivity).
Over the last 10 years, surgical stabilization of rib fractures (SSRF) has emerged as a promising technology for the management of patients with severe chest wall injuries [3]. Conceptually, SSRF applies the fundamental orthopedic principles of reduction and fixation to rib fractures, restoring chest wall stability and minimizing pain with respiration, splinting, and secretion accumulation. The advent of muscle-sparring [4] and even minimally-invasive surgical techniques [5], as well as a relatively low complication rate [6], has improved the appeal of this operation.
To date, three randomized clinical trials (RCTs) [7-9] and three meta-analyses of these and other trials [10-12] have limited their scope to patients with flail chest, a specific clinical diagnosis characterized by paradoxical motion of a portion of the chest wall due to fractures of two or more ribs in at least two places. Flail chest represents the most severe form of chest wall injury, with an associated, very high morbidity and mortality. Each of the aforementioned RCTs, as well as multiple prospective, non-randomized investigations [13, 14], have found a benefit to SSRF as compared to best medical management in this patient population. Accordingly, expert consensus statements have recommended this operation in this subset of patients [3, 15].
Based upon the favorable reported efficacy of SSRF in patients with flail chest, many surgeons have broadened indications to patients with severe, non-flail rib fracture patterns, most commonly ≥ 3 severely displaced fractures. Although these injuries differ anatomically from flail chest, many of the same pathophysiologic principles are at work: namely, painful motion at the fracture sites cause respiratory compromise, bony bridging [16], and risk of subsequent non-union, chronic pain, and restrictive lung disease. However, it is not clear if stabilization of these fractures confers the same benefits as in the case of flail chest. This lack of efficacy data has been recognized in recent guidelines, which were unable to recommend SSRF for non-flail fracture patterns pending further data. Furthermore, long term quality of life data for both flail and non-flail fracture patterns managed with SSRF are not available.
The use of SSRF is increasing exponentially. Somewhat alarmingly, nearly one half of the procedures were performed in patients without flail chest [17]. A combination of the favorable results observed for SSRD in flail chest, the increasing prevalence of SSRF for non flail-chest, and the lack of quality evidence to support this operation in this patient population, lead to the design of the current RCT. The objective of this trial is to investigate the efficacy of SSRF, as compared to non-operative management, for hospitalized patients with specific, non-flail, severe rib fractures, and within expert, high volume centers that participate in the Chest Wall Injury Society. The investigators hypothesize that SSRF, as compared to standardized medical management, improves pain control, pulmonary function, risk of complications, and quality of life among patients with severe, non-flail chest fracture patterns.
Two or more of the following pulmonary physiologic derangements (at the time of consideration for enrollment and after best medical therapy).
Exclusion Criteria:
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Device: Operative
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
Also known as: Surgical stabilization of rib fractures, rib plating
Numeric Pain Score
Patient self-reported pain score on an 11 point scale scale ranging from 0-10; 0 being "no pain" to 10 "the worst pain imaginable".
Time frame: Hospital days 1-7, day of discharge (an average of 1 week) and at 2, 4 and 8 weeks following discharge from hospital.
Length of Stay
Patient length of stay in hospital and/or ICU.
Time frame: 2 months after injury
Daily Narcotic Use
Total standardized narcotic equivalents per day, which is calculated using an equil-analgesic scale: Narcotic Dose Unit Route Hydromorphone 1.5 mg IV Hydromorphone 7.5 mg PO Fentanyl 100 mcg IV Morphine 10 mg IV Morphine 30 mg PO Oxycodone 20 mg PO Hydrocodone 30 mg PO \*IV, intravenous; mcg, micrograms; mg, milligrams; PO, per oral
Time frame: Inpatient: occurred daily at 10 AM while the patient was hospitalized. Post-discharge: occurred at outpatient clinic follow-up encounter that occurred at 2, 4, and 8 weeks post discharge.
Incentive Spirometry
The maximum volume (ml) of inspired air through a handheld device called an incentive spirometer. Best value of 3 attempts is recorded. The value of the inspired volume is normalized for patients age, sex, and height and in measured in the percent predicted for that particular individual.
Time frame: Inpatient: occurred daily at 10 AM while the patient was hospitalized. Post-discharge: occurred at outpatient clinic follow-up encounter that occurred at 2, 4, and 8 weeks post discharge.
Pulmonary Function Testing
Forced expired volume in 1 second, measured in pulmonary function lab
Time frame: once, at first follow-up, outpatient, clinic visit, which occurred at 2 weeks post discharge.
Number of Patients With Pneumonia
CDC definition of nosocomial pneumonia
Time frame: Study participants were followed up to 2 months after index admission date.
Days of Ventilator-dependent Respiratory Failure
Mechanical ventilation for \> 24 hours at any time during index hospitalization
Time frame: Study participants were followed up to 2 months after index admission date.
Chest Wall Specific Quality of Life Questionnaire
An 8 question, validated quality of life (QoL) questionnaire administered at outpatient, clinic follow-up encounters after discharge from the index admission. Minimum score is 0 and indicates the worst outcome of QoL while maximum score is 55, which indicates the highest outcome of QoL.
Time frame: 2, 4 and 8 weeks after discharge from the index admission
| Milestone | Operative | Non-Operative |
|---|---|---|
| Started | 51 | 59 |
| Completed | 51 | 59 |
| Not completed | 0 | 0 |
Patient self-reported pain score on an 11 point scale scale ranging from 0-10; 0 being "no pain" to 10 "the worst pain imaginable".
| score on a scale | Operative | Non-operative |
|---|---|---|
| Hospital day 1 | 7.5 ± 2.4 | 7 ± 2.3 |
| Hospital day 2 | 6.3 ± 2.6 | 6.0 ± 2.4 |
| Hospital day 3 | 5.3 ± 2.8 | 5.9 ± 2.1 |
| Hospital day 4 | 5.3 ± 2.8 | 6.1 ± 2.4 |
| Hospital day 5 | 5.0 ± 2.3 | 5.9 ± 2 |
| Hospital day 6 | 4.7 ± 2.1 | 5.8 ± 2.1 |
| Hospital day 7 | 4.7 ± 2.6 | 6.3 ± 2.3 |
| Day of discharge | 4.1 ± 2.3 | 5.2 ± 2.4 |
| 2 week follow-up | 2.9 ± 2.1 | 4.5 ± 2.2 |
| 4 week follow-up | 2.4 ± 2.4 | 3.3 ± 2.6 |
| 8 week follow-up | 1.5 ± 1.3 | 3.3 ± 2.7 |
Patient length of stay in hospital and/or ICU.
| Days | Operative | Non-operative |
|---|---|---|
| Hospital length of stay | 7 (5.5 to 10) | 6 (4 to 11) |
| ICU length of stay | 2 (0 to 3) | 2 (0 to 3) |
Total standardized narcotic equivalents per day, which is calculated using an equil-analgesic scale: Narcotic Dose Unit Route Hydromorphone 1.5 mg IV Hydromorphone 7.5 mg PO Fentanyl 100 mcg IV Morphine 10 mg IV Morphine 30 mg PO Oxycodone 20 mg PO Hydrocodone 30 mg PO \*IV, intravenous; mcg, micrograms; mg, milligrams; PO, per oral
| mg morphine equivalents | Operative | Non-operative |
|---|---|---|
| Hospital Day 1 | 2.6 (1.3 to 4.5) | 1.6 (0.5 to 2.6) |
| Hospital Day 2 | 2.0 (0.8 to 3.3) | 2.0 (1.3 to 2.8) |
| Hospital Day 3 | 1.5 (0.8 to 3) | 1.6 (1 to 2.3) |
| Hospital Day 4 | 1.5 (0.5 to 3) | 1.5 (0.8 to 2.7) |
| Hospital Day 5 | 1.3 (0.6 to 2.3) | 2.3 (1 to 3) |
| Hospital Day 6 | 1.3 (0.3 to 2.3) | 2.0 (1 to 3.5) |
| Hospital Day 7 | 1.0 (0.5 to 2) | 2.3 (0.8 to 3.8) |
| Day of Discharge | 0.5 (0.3 to 1.5) | 0.8 (0.5 to 1.5) |
| 2 Week Follow-up | 0.5 (0 to 1.3) | 1.2 (0.8 to 3) |
| 4 Week Follow-up | 0.3 (0 to 0.6) | 1.5 (0 to 2) |
| 8 Week Follow-up | 0.2 (0 to 0.5) | 0.5 (0.3 to 1.3) |
The maximum volume (ml) of inspired air through a handheld device called an incentive spirometer. Best value of 3 attempts is recorded. The value of the inspired volume is normalized for patients age, sex, and height and in measured in the percent predicted for that particular individual.
| % of predicted ml for age/sex/height | Operative | Non-operative |
|---|---|---|
| Hosp Day 1 | 39 (21 to 61) | 39.5 (27.5 to 49.5) |
| Hosp Day 2 | 40 (23 to 59) | 41.5 (32 to 60) |
| Hosp Day 3 | 46 (31 to 65) | 49 (42 to 64) |
| Hosp Day 4 | 48.5 (33.5 to 67.5) | 49.5 (42 to 66) |
| Hosp Day 5 | 59 (37 to 66) | 51 (42 to 59) |
| Hosp Day 6 | 52 (41 to 67) | 49 (41.5 to 60) |
| Hosp Day 7 | 55 (45 to 72) | 54 (37 to 70) |
| Day of Discharge | 63 (55 to 78) | 61 (49 to 74) |
| 2 Week Follow-Up | 87 (63 to 100) | 90 (73 to 100) |
| 4 Week Follow-Up | 100 (68 to 112) | 100 (85 to 113) |
| 8 Week Follow-Up | 100 (81 to 120.5) | 97.5 (77 to 141) |
Forced expired volume in 1 second, measured in pulmonary function lab
| % of predicted ml for age/sex/height | Operative | Non-operative |
|---|---|---|
| Pulmonary Function Testing | 75.5 ± 17.6 | 75.8 ± 15.8 |
CDC definition of nosocomial pneumonia
| Participants | Operative | Non-operative |
|---|---|---|
| Number of Patients With Pneumonia | 1 | 4 |
Mechanical ventilation for \> 24 hours at any time during index hospitalization
| Days | Operative | Non-operative |
|---|---|---|
| Days of Ventilator-dependent Respiratory Failure | 0 (0 to 0) | 0 (0 to 0) |
An 8 question, validated quality of life (QoL) questionnaire administered at outpatient, clinic follow-up encounters after discharge from the index admission. Minimum score is 0 and indicates the worst outcome of QoL while maximum score is 55, which indicates the highest outcome of QoL.
| units on a scale | Operative | Non-operative |
|---|---|---|
| 2 Week Follow-Up | 20.6 ± 11 | 25.3 ± 10.1 |
| 4 Week Follow-Up | 16.9 ± 10.6 | 22.4 ± 8.8 |
| 8 Week Follow-Up | 10.4 ± 10.9 | 15.7 ± 8.2 |
Collected over 2 months after study participant was discharged from index admission.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Operative | 0/51 (0%) | 0/51 (0%) | 1/51 (2%) |
| Non-operative | 0/59 (0%) | 0/59 (0%) | 3/59 (5.1%) |
| Event | Operative | Non-operative |
|---|---|---|
| Take back to operating room for bleedingRespiratory, thoracic and mediastinal disorders | 1/51 | 0/59 |
| Local InfectionRespiratory, thoracic and mediastinal disorders | 0/51 | 1/59 |
| Systemic InfectionImmune system disorders | 0/51 | 1/59 |
| Acute Kidney InjuryRenal and urinary disorders | 0/51 | 1/59 |
| Age, Continuous(years) | Operative | Non-Operative | Total |
|---|---|---|---|
| Mean | 54.6 ± 15.4 | 53.2 ± 16.1 | 53.6 ± 15.2 |
| Sex: Female, Male(Participants) | Operative | Non-Operative | Total |
|---|---|---|---|
| Female | 12 | 16 | 28 |
| Male | 39 | 43 | 82 |
| Race and Ethnicity Not Collected(Participants) | Operative | Non-Operative | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Operative | Non-Operative | Total |
|---|---|---|---|
| United States | 51 | 59 | 110 |
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Denver Health and Hospital Authority