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

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

Study Overview

• Status: Unknown
• Conditions: Polytraumatises With Rib Fractures
• Intervention / Treatment: Device: Thoracic osteosyntheses with Stracos

• Study Type: Interventional
• Enrollment (Anticipated): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • Recruiting
    • Hospital University of Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Device: Thoracic osteosyntheses with Stracos
NO_INTERVENTION: Medical treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: November 22, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (ESTIMATE): December 18, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Flail Chest; Rib Fractures
• Other Study ID Numbers: 2014-A01844-43