Operative Treatment of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma

Study Overview
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Brief Summary
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The purpose of this prospective controlled study is to determine whether surgical management of unstable thoracic cage injuries and chest wall deformity in trauma reduces the need for and the time spent on ventilator compared to a group treated without operation.

Detailed Description
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Patients meeting the inclusion criteria and giving their informed consent will be enrolled in this prospective controlled study. Included patients at Sahlgrenska University Hospital will undergo surgical stabilization of chest wall injuries and patients at Karolinska University Hospital will be managed conservatively. A total of 60 patients will be included in each group. 3D reconstructions of computed tomography images of the Thorax done at admission to the hospital will be used in order to evaluate injury according to Lung Injury Scale and Chest wall Injury Scale and for calculating radiological lung volumes and plan surgical procedure in the intervention group. Surgery will be performed as soon as possible after inclusion. MatrixRIB® (DePuy Synthes) Fixation system is used for stabilizing rib fractures with plates and angular locked screws. In cases where thoracotomy is done the patients will receive an anterior and posterior chest tube and wound drain with active suction. All patients, both in the intervention and in the control group will be offered thoracic epidural anaesthesia. Broad-spectrum intravenous antibiotic therapy is given as long as the patient has chest tubes. Thrombotic prophylaxis with LMWH is given until the patient is mobilized but for a minimum of 7 days. Patients will be followed-up 6 weeks, 6 months and 1 year post-operatively by surgeon and physiotherapist. A low-dosage computer tomography of the thorax will be done after 6 months in order to evaluate healing of the rib cage, possible non-union or dysfunction of osteosynthetic material and measure remaining lung volume. This examination will be compared to the initial computer tomography image done when the patient was admitted. At follow-ups complaints, possible late complications, usage of analgesia and return to work will be recorded. Evaluated instruments, EQ-5D-5L, VAS with Pain-O-Meter (POM) and Disability Rating Index (DRI) will be used to evaluate quality of life, pain and physical function. Range of motion in the thorax, thoracic spine and shoulders will be evaluated for every patient. Breathing movements will be measured by using a Respiratory movement measuring instrument (RMMI, ReMo Inc) and lung function tests will be performed in a standardized manner. In order to enrich the material, hospital data from patients fulfilling the inclusion criteria but not included, at the two study locations, during the inclusion period (June 2014 - June 2017) will be analyzed. An additional Ethical approval has been granted.

Official Title
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Prospective Controlled Study of Surgical Management of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma

Conditions
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Trauma, Flail Chest, Rib Fractures, Surgery

Intervention / Treatment
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* Drug: NSAID
* Drug: Opioids
* Drug: Thoracic Epidural anaesthesia
* Drug: Paracetamol
* Procedure: Surgical management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trauma with segmental rib fractures on at least 3 adjacent ribs ( anatomical flail chest ) Trauma with chest wall deformity Exclusion Criteria: Concurrent spinal cord injuries with paralysis Severe head injury where normal level of consciousness is not resumed Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical management<br>Operative fixation of unstable thoracic cage injuries and chest wall deformity. Thoracic Epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication. | Drug: NSAID<br>* Will be used if tolerated.<br>* Other names: Ibuprofen;Drug: Opioids<br>* Initially intravenous administration and when tolerated oral slow-release pils will be used.<br>* Other names: Morphine;Drug: Thoracic Epidural anaesthesia<br>* Given by specialists in anaesthesiology and intensive care.<br>* Other names: Continous thoracic epidural anaesthesia will be offered.;Drug: Paracetamol<br>* 1g QID will be given to all patients unless allergies.<br>* Other names: Panodil;Procedure: Surgical management<br>* Fracture stabilization<br>* Other names: Matrix Rib Fixation System (DePuy Synthes).;|
| Active Comparator: Conservative management<br>Conservative management of unstable thoracic cage injuries and chest wall deformity. Thoracic epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication. | Drug: NSAID<br>* Will be used if tolerated.<br>* Other names: Ibuprofen;Drug: Opioids<br>* Initially intravenous administration and when tolerated oral slow-release pils will be used.<br>* Other names: Morphine;Drug: Thoracic Epidural anaesthesia<br>* Given by specialists in anaesthesiology and intensive care.<br>* Other names: Continous thoracic epidural anaesthesia will be offered.;Drug: Paracetamol<br>* 1g QID will be given to all patients unless allergies.<br>* Other names: Panodil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory insufficiency | Need and length of ventilation therapy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Time spent in an intensive care unit and total length of hospital stay | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective study, Surgical management, Unstable thoracic cage injuries, Trauma, Ventilator support