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

Poitiers University Hospital

Status: Unknown

Conditions: Polytraumatises With Rib Fractures

Treatments: Device: Thoracic osteosyntheses with Stracos

Study type: Interventional

Funder types: Other

Identifiers

NCT02635165

2014-A01844-43

Details and patient eligibility

About

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

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

Surgical treatment with Stracos

Active Comparator group

Description:

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.

Treatment:

Device: Thoracic osteosyntheses with Stracos

Medical treatment

No Intervention group