TraumaNCT02132416
Operative Treatment of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma
A study testing NSAID, Opioids and Thoracic Epidural anaesthesia in people with Trauma and Flail Chest, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Flail Chest, Rib Fractures
- What is being tested?
- NSAID, Opioids and Thoracic Epidural anaesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesSweden
- Study dates
- May 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma with segmental rib fractures on at least 3 adjacent ribs ( anatomical flail chest )
- Trauma with chest wall deformity
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Sweden2 sites
Departement of Surgery, Sahlgrenska University Hospital
Gothenburg, 413 45
Departement of Intensive Care, Karolinska University Hospital
Stockholm, 171 76
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma, Flail Chest, Rib Fractures, Surgery
- Being tested
- NSAID, Opioids, Thoracic Epidural anaesthesia, Paracetamol, Surgical management
- Keywords
- Prospective study, Surgical management, Unstable thoracic cage injuries, Trauma, Ventilator support
- Medical subject headings
- Wounds and Injuries, Flail Chest, Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDDrug
Also called Diclofenac, Naprosyn, Ibuprofen
Will be used if tolerated.
OpioidsDrug
Also called Tramadol, Oxycodone, Morphine
Initially intravenous administration and when tolerated oral slow-release pils will be used.
Thoracic Epidural anaesthesiaDrug
Also called Continous thoracic epidural anaesthesia will be offered.
Given by specialists in anaesthesiology and intensive care.
ParacetamolDrug
Also called Paracet, Alvedon, Panodil
1g QID will be given to all patients unless allergies.
Surgical managementProcedure or surgery
Also called Matrix Rib Fixation System (DePuy Synthes).
Fracture stabilization
| Study group | Role | What they receive |
|---|---|---|
| Surgical management | Active comparator | 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. Receives: Drug: NSAID; Drug: Opioids; Drug: Thoracic Epidural anaesthesia; Drug: Paracetamol; Procedure: Surgical management |
| Conservative management | Active comparator | 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. Receives: Drug: NSAID; Drug: Opioids; Drug: Thoracic Epidural anaesthesia; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory insufficiency
Need and length of ventilation therapy
Measured: 1 year
Secondary outcomes (1)
Hospital stay
Time spent in an intensive care unit and total length of hospital stay
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Eva-Corina Caragounis, Sahlgrenska University Hospital
- Investigators
- Hans Granhed, MD PhD, Study director, Sahlgrenska University HospitalEva-Corina Caragounis, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132416
- Sponsor's protocol ID
- ec761218
- Other IDs
- epn887-13
- Status last verified
- Jan 2019
- First submitted
- 1 May 2014
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Caragounis EC, Fagevik Olsen M, Sandstrom L, Rossi Norrlund R, Strommer L, Granhed H. A bi-institutional observational study comparing short-term and long-term outcome of operative and non-operative management of clinical and radiological flail chest injuries. Scand J Trauma Resusc Emerg Med. 2025 May 15;33(1):87. doi: 10.1186/s13049-025-01400-8.
PubMed 40375321
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Study of Surgical Management of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma
- ClinicalTrials.gov ID
- NCT02132416
- Acronym / sponsor ID
- ec761218
- Conditions
- Trauma, Flail Chest, Rib Fractures, Surgery
- Keywords
- Prospective study, Surgical management, Unstable thoracic cage injuries, Trauma, Ventilator support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- May 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical management | Active comparator | Drug: NSAID, Drug: Opioids, Drug: Thoracic Epidural anaesthesia, Drug: Paracetamol, Procedure: Surgical managementOperative 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. |
| Conservative management | Active comparator | Drug: NSAID, Drug: Opioids, Drug: Thoracic Epidural anaesthesia, Drug: ParacetamolConservative 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Trauma with segmental rib fractures on at least 3 adjacent ribs ( anatomical flail chest )
- Trauma with chest wall deformity
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSAIDAlso: Diclofenac, Naprosyn, IbuprofenWill be used if tolerated. | Drug | Conservative management, Surgical management |
| OpioidsAlso: Tramadol, Oxycodone, MorphineInitially intravenous administration and when tolerated oral slow-release pils will be used. | Drug | Conservative management, Surgical management |
| Thoracic Epidural anaesthesiaAlso: Continous thoracic epidural anaesthesia will be offered.Given by specialists in anaesthesiology and intensive care. | Drug | Conservative management, Surgical management |
| ParacetamolAlso: Paracet, Alvedon, Panodil1g QID will be given to all patients unless allergies. | Drug | Conservative management, Surgical management |
| Surgical managementAlso: Matrix Rib Fixation System (DePuy Synthes).Fracture stabilization | Procedure or surgery | Surgical management |
Primary outcome
Respiratory insufficiency
Time frame: 1 year
Need and length of ventilation therapy
1 secondary outcome
Hospital stay
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 40375321Caragounis EC, Fagevik Olsen M, Sandstrom L, Rossi Norrlund R, Strommer L, Granhed H. A bi-institutional observational study comparing short-term and long-term outcome of operative and non-operative management of clinical and radiological flail chest injuries. Scand J Trauma Resusc Emerg Med. 2025 May 15;33(1):87. doi: 10.1186/s13049-025-01400-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Granhed, MD PhD study director
Sahlgrenska University Hospital
Eva-Corina Caragounis, MD principal investigator
Sahlgrenska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSAID, Opioids and Thoracic Epidural anaesthesia in people with Trauma and Flail Chest, run by Sahlgrenska University Hospital at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory insufficiency (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02132416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.