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

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

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Surgery; Flail Chest; Rib Fractures
• Intervention / Treatment: Drug: NSAID; Drug: Opioids; Drug: Thoracic Epidural anaesthesia; Drug: Paracetamol; Procedure: Surgical management

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Departement of Surgery, Sahlgrenska University Hospital
  • Stockholm, Sweden, 171 76
    • Departement of Intensive Care, Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgical management; 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; Will be used if tolerated.; Other Names: Diclofenac; Ibuprofen; Naprosyn; Drug: Opioids; Initially intravenous administration and when tolerated oral slow-release pils will be used.; Other Names: Morphine; Oxycodone; Tramadol; Drug: Thoracic Epidural anaesthesia; Given by specialists in anaesthesiology and intensive care.; Other Names: Continous thoracic epidural anaesthesia will be offered.; Drug: Paracetamol; 1g QID will be given to all patients unless allergies.; Other Names: Panodil; Paracet; Alvedon; Procedure: Surgical management; Fracture stabilization; Other Names: Matrix Rib Fixation System (DePuy Synthes).
Active Comparator: Conservative management; 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; Will be used if tolerated.; Other Names: Diclofenac; Ibuprofen; Naprosyn; Drug: Opioids; Initially intravenous administration and when tolerated oral slow-release pils will be used.; Other Names: Morphine; Oxycodone; Tramadol; Drug: Thoracic Epidural anaesthesia; Given by specialists in anaesthesiology and intensive care.; Other Names: Continous thoracic epidural anaesthesia will be offered.; Drug: Paracetamol; 1g QID will be given to all patients unless allergies.; Other Names: Panodil; Paracet; Alvedon

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability Rating Index	Pain, function and mobility	1 year
Quality of Life; EQ5D5L and VAS	EQ-5D-5L instrument has a subscale of; 1 (no problems), 2 (slight problems), 3 (moderate problems), 4 (severe problems) and 5 (extreme problems). The Visual Analogue scale is a self-rating scale from 0% (the worst Health you can imagine) to 100% (the best Health you can imagine).	Time Frame

Collaborators and Investigators

• Sponsor: Sahlgren´s University Hospital
• Collaborators: Karolinska University Hospital; Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 1, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Trauma; Prospective study; Surgical management; Unstable thoracic cage injuries; Ventilator support
• Additional Relevant MeSH Terms: Fractures, Bone; Thoracic Injuries; Wounds and Injuries; Flail Chest; Rib Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Anesthetics; Acetaminophen; Morphine; Diclofenac; Ibuprofen; Tramadol; Oxycodone
• Other Study ID Numbers: ec761218; epn887-13 (REGISTRY: Ethical approval committe)