Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos

Study Overview
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Brief Summary
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Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by decreasing the length of stay and the late complications: pain chronicles, quality of life, respiratory function

Official Title
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Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos

Conditions
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Polytraumatises With Rib Fractures

Intervention / Treatment
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* Device: Thoracic osteosyntheses with Stracos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with flail chest including bifocal fracture of three or more consecutive ribs in at least two places with or without paradoxical movement The surgical procedure was performed in the first 48 hours after admission pathology with prognosis for survival 6-month-old inferior Exclusion Criteria: Paraplegia or Tetraplegia Patients having the necessity of neurosurgical treatment or reanimation of neurosurgical Aorta hematoma or rupture ß-HCG positive in women titanium allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical treatment with Stracos<br>The patient was placed in the lateral decubitus position. The procedure involved a curvilinear thoracic incision overlying the center of the fractured segments. The intercostal muscles were dissected off the rib on its superior aspect away from the fracture site, and the fracture was then reduced. The investigators then chose the most suitable Stracos, which is to be found in two available sizes, 6 or 9 claws, according to the length of the fracture. The clip chosen was molded according to the shape of the corresponding rib and the claws were crimped using special pliers on and around the fractured rib.The investigators treated only one rib out of two with Stracos, and as for displaced or comminuted fractures, the adjacent rib was wrapped using vicryl suture on the osteosynthesis rib. | Device: Thoracic osteosyntheses with Stracos<br> <br> |
| No Intervention: Medical treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average cost hospitalization | Average cost hospitalization without the intensive care cost.The cost of the hospitalization will be calculated by adding the cost of the surgery and hospital stay- time of the surgery-The number of Stracos used by patient | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stays of the intensive care department | From the first day to the last day in the intensive care department. Care department - monitoring patients with traumatic hemothorax - lung pulmonary infectious associated - | 4 weeks | 
| length of hospital stays | From the first day to the last day in the hospital | 4 weeks | 
| occurence of pulmonary infection |  | 12 months of follow up | 
| The vital capacity (VC) | Volume measurement (L) | visit 3 months, visit 6 months, visit 12 months after the surgery | 
| The expiratory reserve volume (ERV) | Volume measurement (L) | visit 3 months, visit 6 months, visit 12 months after the surgery | 
| The total lung capacity (TLC) | Volume measurement (L) | visit 3 months, visit 6 months, visit 12 months after the surgery | 
| Residual volume (RV) | Volume measurement (L) | visit 3 months, visit 6 months, visit 12 months after the surgery | 
| 6 min walk test (6MWT) | Distance measurement (M) | visit 3 months, visit 6 months, visit 12 months after the surgery | 
| Visual analog scorer for pain |  | at visit 7 days, 28 days, 3 months, 6 months and 12 months | 
| Patient Global Assessment to measure quality of life |  | at visit 7 days, 28 days, 3 months, 6 months and 12 months | 
| date of return to work |  | visit 3 months, 6 months and 12 months |