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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02635165
Acronym
EMVOLS
Enrollment
310
Registered
2015-12-18
Start date
2015-11-30
Completion date
2020-12-31
Last updated
2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polytraumatises With Rib Fractures

Brief summary

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

Interventions

DEVICEThoracic osteosyntheses with Stracos

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average cost hospitalization4 weeksAverage 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

Secondary

MeasureTime frameDescription
length of hospital stays4 weeksFrom the first day to the last day in the hospital
occurence of pulmonary infection12 months of follow up
The vital capacity (VC)visit 3 months, visit 6 months, visit 12 months after the surgeryVolume measurement (L)
The expiratory reserve volume (ERV)visit 3 months, visit 6 months, visit 12 months after the surgeryVolume measurement (L)
The total lung capacity (TLC)visit 3 months, visit 6 months, visit 12 months after the surgeryVolume measurement (L)
length of hospital stays of the intensive care department4 weeksFrom the first day to the last day in the intensive care department. Care department - monitoring patients with traumatic hemothorax - lung pulmonary infectious associated -
6 min walk test (6MWT)visit 3 months, visit 6 months, visit 12 months after the surgeryDistance measurement (M)
Visual analog scorer for painat visit 7 days, 28 days, 3 months, 6 months and 12 months
Patient Global Assessment to measure quality of lifeat visit 7 days, 28 days, 3 months, 6 months and 12 months
date of return to workvisit 3 months, 6 months and 12 months
Residual volume (RV)visit 3 months, visit 6 months, visit 12 months after the surgeryVolume measurement (L)

Countries

France

Contacts

Primary ContactChristophe CJ JAYLE, PI
christophe.jayle@chu-poitiers.fr05.49.44.30.07

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026