Clinical trial NCT02132416: Operative Treatment of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma
Official title: Prospective Controlled Study of Surgical Management of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Flail Chest
Rib Fractures
Surgery
Keywords: Prospective study
Surgical management
Unstable thoracic cage injuries
Trauma
Ventilator support
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2014-05-07
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory insufficiency
timeFrame: 1 year
Secondary outcomes:
measure: Hospital stay
timeFrame: 6 weeks
Other outcomes:
measure: Disability Rating Index
timeFrame: 1 year
measure: Quality of Life; EQ5D5L and VAS
timeFrame: Time Frame
Locations:
city: Gothenburg
country: Sweden
facility: Departement of Surgery, Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Departement of Intensive Care, Karolinska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Hans Granhed, MD PhD
role: STUDY_DIRECTOR
affiliation: Sahlgrenska University Hospital
name: Eva-Corina Caragounis, MD
role: PRINCIPAL_INVESTIGATOR
References: