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

Sahlgrenska University Hospital

Status: Completed

Conditions: Flail Chest; Surgery; Trauma; Rib Fractures

Treatments: Drug: NSAID; Drug: Thoracic Epidural anaesthesia; Drug: Paracetamol; Procedure: Surgical management; Drug: Opioids

Study type: Interventional

Funder types: Other

Identifiers

NCT02132416

epn887-13 (Registry Identifier)

ec761218

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Surgical management

Active Comparator group

Description:

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.

Treatment:

Drug: Opioids

Procedure: Surgical management

Drug: Paracetamol

Drug: Thoracic Epidural anaesthesia

Drug: NSAID

Conservative management

Active Comparator group

Description:

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.

Treatment:

Drug: Opioids

Drug: Paracetamol

Drug: Thoracic Epidural anaesthesia

Drug: NSAID