Multicenter RCT of SSRF in Non Flail Patients

NCT ID: NCT03221595

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2020-01-01

Brief 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.

Detailed Description

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.

Conditions

Rib Fracture Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Operative

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.

Group Type: EXPERIMENTAL

Operative

Intervention Type: DEVICE

This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints

Non-operative

Patients in the non operative arm will undergo best medical management of their displaced rib fractures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Operative

This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints

Intervention Type: DEVICE

Other Intervention Names

Surgical stabilization of rib fractures, rib plating

Eligibility Criteria

Inclusion Criteria

1. Hospitalization with ≥ 3 severely displaced (≥ 50% of rib width) acute rib fractures.

2. Two or more of the following pulmonary physiologic derangements (at the time of consideration for enrollment and after best medical therapy).

1. Respiratory rate > 20 breaths per minute

2. Incentive spirometry < 50% predicted (appendix D)

3. Numeric pain score > 5

4. Poor cough (as documented by respiratory therapist)

3. Surgery anticipated < 72 hours from injury

Exclusion Criteria

1. Age < 18 years or ≥ 80 years

2. 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.

3. Moderate or severe traumatic brain injury (GCS at the time of consideration for enrollment < 12)

4. Intubation

5. Severe pulmonary contusion, defined as Blunt Pulmonary Contusion 18 (BPC18) score > 12 [19].

6. Prior or expected emergency exploratory laparotomy during this admission.

7. Prior or expected emergency thoracotomy during this admission.

8. Prior or expected emergency craniotomy during this admission.

9. Spinal cord injury

10. Pelvic fracture that has required, or is expected to require, operative intervention during this admission.

11. The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, prepearing meals).

12. Pregnancy.

13. Incarceration.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Synthes

INDUSTRY

Sponsor Role: collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fredric M Pieracci, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Denver Health Medical Center

Locations

Denver Health Medical Center

Denver, Colorado, United States

Countries

United States

References

Pieracci FM, Majercik S, Ali-Osman F, Ang D, Doben A, Edwards JG, French B, Gasparri M, Marasco S, Minshall C, Sarani B, Tisol W, VanBoerum DH, White TW. Consensus statement: Surgical stabilization of rib fractures rib fracture colloquium clinical practice guidelines. Injury. 2017 Feb;48(2):307-321. doi: 10.1016/j.injury.2016.11.026. Epub 2016 Nov 27. No abstract available.

Reference Type: BACKGROUND

PMID: 27912931 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

COMIRB 17-1432

Identifier Type: -

Identifier Source: org_study_id