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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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 Summary: 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 phys
Sponsor: Sahlgren´s University Hospital

Current Primary Outcome: Respiratory insufficiency [ Time Frame: 1 year ]

Need and length of ventilation therapy


Original Primary Outcome: Same as current

Current Secondary Outcome: Hospital stay [ Time Frame: 6 weeks ]

Time spent in an intensive care unit and total length of hospital stay


Original Secondary Outcome: Same as current

Information By: Sahlgren´s University Hospital

Dates:
Date Received: May 1, 2014
Date Started: May 2014
Date Completion: May 2016
Last Updated: November 21, 2014
Last Verified: November 2014