We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02132416
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Karolinska University Hospital
Information provided by (Responsible Party):
Eva-Corina Caragounis, Sahlgren´s University Hospital

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.

Condition or disease Intervention/treatment Phase
Trauma Flail Chest Rib Fractures Surgery Drug: NSAID Drug: Opioids Drug: Thoracic Epidural anaesthesia Drug: Paracetamol Procedure: Surgical management Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Controlled Study of Surgical Management of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma
Actual Study Start Date : May 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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
  • Naprosyn
  • Ibuprofen

Drug: Opioids
Initially intravenous administration and when tolerated oral slow-release pils will be used.
Other Names:
  • Tramadol
  • Oxycodone
  • Morphine

Drug: Thoracic Epidural anaesthesia
Given by specialists in anaesthesiology and intensive care.
Other Name: Continous thoracic epidural anaesthesia will be offered.

Drug: Paracetamol
1g QID will be given to all patients unless allergies.
Other Names:
  • Paracet
  • Alvedon
  • Panodil

Procedure: Surgical management
Fracture stabilization
Other Name: 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
  • Naprosyn
  • Ibuprofen

Drug: Opioids
Initially intravenous administration and when tolerated oral slow-release pils will be used.
Other Names:
  • Tramadol
  • Oxycodone
  • Morphine

Drug: Thoracic Epidural anaesthesia
Given by specialists in anaesthesiology and intensive care.
Other Name: Continous thoracic epidural anaesthesia will be offered.

Drug: Paracetamol
1g QID will be given to all patients unless allergies.
Other Names:
  • Paracet
  • Alvedon
  • Panodil




Primary Outcome Measures :
  1. Respiratory insufficiency [ Time Frame: 1 year ]
    Need and length of ventilation therapy


Secondary Outcome Measures :
  1. Hospital stay [ Time Frame: 6 weeks ]
    Time spent in an intensive care unit and total length of hospital stay


Other Outcome Measures:
  1. Disability Rating Index [ Time Frame: 1 year ]
    Pain, function and mobility

  2. Quality of Life; EQ5D5L and VAS [ Time Frame: Time Frame ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132416


Locations
Layout table for location information
Sweden
Departement of Surgery, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Departement of Intensive Care, Karolinska University Hospital
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Sahlgren´s University Hospital
Sahlgrenska University Hospital, Sweden
Karolinska University Hospital
Investigators
Layout table for investigator information
Study Director: Hans Granhed, MD PhD Sahlgrenska University Hospital, Sweden
Principal Investigator: Eva-Corina Caragounis, MD Sahlgrenska University Hospital, Sweden
Layout table for additonal information
Responsible Party: Eva-Corina Caragounis, MD, Sahlgren´s University Hospital
ClinicalTrials.gov Identifier: NCT02132416    
Other Study ID Numbers: ec761218
epn887-13 ( Registry Identifier: Regional Ethical Board )
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Keywords provided by Eva-Corina Caragounis, Sahlgren´s University Hospital:
Prospective study
Surgical management
Unstable thoracic cage injuries
Trauma
Ventilator support
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Rib Fractures
Flail Chest
Fractures, Bone
Thoracic Injuries
Acetaminophen
Ibuprofen
Diclofenac
Morphine
Oxycodone
Tramadol
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics