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

NCT ID: NCT02635165

Last Updated: 2019-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-12-31

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

Detailed Description

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Conditions

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Polytraumatises With Rib Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical treatment with Stracos

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.

Group Type ACTIVE_COMPARATOR

Thoracic osteosyntheses with Stracos

Intervention Type DEVICE

Medical treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Thoracic osteosyntheses with Stracos

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital University of Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christophe CJ JAYLE, PI

Role: CONTACT

05.49.44.30.07

Other Identifiers

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2014-A01844-43

Identifier Type: -

Identifier Source: org_study_id

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