Polytraumatises With Rib FracturesEMVOLSNCT02635165
Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos
A study testing Thoracic osteosyntheses with Stracos in people with Polytraumatises With Rib Fractures, run by Poitiers University Hospital at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polytraumatises With Rib Fractures
- What is being tested?
- Thoracic osteosyntheses with Stracos
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospital University of Poitiers
Poitiers, 86021
About this study
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
- Conditions
- Polytraumatises With Rib Fractures
- Being tested
- Thoracic osteosyntheses with Stracos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic osteosyntheses with StracosDevice
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment with Stracos | Active comparator | 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. Receives: Device: Thoracic osteosyntheses with Stracos |
| Medical treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (11)
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 -
Measured: 4 weeks
length of hospital stays
From the first day to the last day in the hospital
Measured: 4 weeks
occurence of pulmonary infection
Measured: 12 months of follow up
The vital capacity (VC)
Volume measurement (L)
Measured: visit 3 months, visit 6 months, visit 12 months after the surgery
The expiratory reserve volume (ERV)
Volume measurement (L)
Measured: visit 3 months, visit 6 months, visit 12 months after the surgery
The total lung capacity (TLC)
Volume measurement (L)
Measured: visit 3 months, visit 6 months, visit 12 months after the surgery
Residual volume (RV)
Volume measurement (L)
Measured: visit 3 months, visit 6 months, visit 12 months after the surgery
6 min walk test (6MWT)
Distance measurement (M)
Measured: visit 3 months, visit 6 months, visit 12 months after the surgery
Visual analog scorer for pain
Measured: at visit 7 days, 28 days, 3 months, 6 months and 12 months
Patient Global Assessment to measure quality of life
Measured: at visit 7 days, 28 days, 3 months, 6 months and 12 months
date of return to work
Measured: visit 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polytraumatises With Rib FracturesStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635165
- Sponsor's protocol ID
- 2014-A01844-43
- Acronym
- EMVOLS
- Status last verified
- Apr 2019
- First submitted
- 22 Nov 2015
- Last updated
- 8 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos
- ClinicalTrials.gov ID
- NCT02635165
- Acronym / sponsor ID
- EMVOLS / 2014-A01844-43
- Conditions
- Polytraumatises With Rib Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment with Stracos | Active comparator | Device: Thoracic osteosyntheses with StracosThe 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. |
| Medical treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic osteosyntheses with Stracos | Device | Surgical treatment with Stracos |
Primary outcome
Average cost hospitalization
Time frame: 4 weeks
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
11 secondary outcomes
length of hospital stays of the intensive care department
Time frame: 4 weeks
length of hospital stays
Time frame: 4 weeks
occurence of pulmonary infection
Time frame: 12 months of follow up
The vital capacity (VC)
Time frame: visit 3 months, visit 6 months, visit 12 months after the surgery
The expiratory reserve volume (ERV)
Time frame: visit 3 months, visit 6 months, visit 12 months after the surgery
The total lung capacity (TLC)
Time frame: visit 3 months, visit 6 months, visit 12 months after the surgery
Residual volume (RV)
Time frame: visit 3 months, visit 6 months, visit 12 months after the surgery
6 min walk test (6MWT)
Time frame: visit 3 months, visit 6 months, visit 12 months after the surgery
Visual analog scorer for pain
Time frame: at visit 7 days, 28 days, 3 months, 6 months and 12 months
Patient Global Assessment to measure quality of life
Time frame: at visit 7 days, 28 days, 3 months, 6 months and 12 months
date of return to work
Time frame: visit 3 months, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic osteosyntheses with Stracos in people with Polytraumatises With Rib Fractures, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe CJ JAYLE, PI (05.49.44.30.07, christophe.jayle@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average cost hospitalization (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.