Multicenter RCT of SSRF in Non Flail Patients
Condition: Rib Fracture Multiple
MeSH terms: Fractures, Bone; Rib Fractures; Fractures, Multiple
Study type: Interventional

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.
    

Intervention name(s): Operative
Intervention type(s): Device
Intervention description(s): This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
Other intervention name(s): Surgical stabilization of rib fractures, rib plating
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, controlled trial
Masking: None (Open Label)
Primary purpose: Other