Rib; Fracture, Multiple, With Flail ChestNCT04710602
Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma
An observational study of Rib; Fracture, Multiple, With Flail Chest, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to assess the outcome of a muscle sparing, minimally invasive open surgical technique for unstable ribcage injuries after trauma. The investigators will compare the results from the study participants to a historical cohort who were operated with a different surgical technique with large… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib; Fracture, Multiple, With Flail Chest
- What is being tested?
- Minimally invasive surgical fixation of unstable rib cage and Large incision surgical fixation of unstable rib cage.
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2021to 11 May 2023
- Phase
- Observational
- 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
Study population: Patients surgically treated at our trauma ward for unstable chest wall due to trauma. Consecutive sampling.
Who may be able to join
- Patients with chest wall trauma who underwent surgical stabilisation for unstable chest wall using a minimally invasive, muscle sparing technique without thoracotomy or thoracoscopy no more than 6 months prior to inclusion.
Who cannot join
- Severe head injury (Abbreviated Injury score (AIS) >3)
- Spinal injury
- Neurological or musculoskeletal disease affecting chest wall mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Follow-up of Patients Treated With Muscle Sparing, Minimally Invasive Open Surgical Technique for Unstable Chest Wall After Trauma
The purpose of this study is to assess the outcome of a muscle sparing, minimally invasive open surgical technique for unstable ribcage injuries after trauma. The investigators will compare the results from the study participants to a historical cohort who were operated with a different surgical technique with large incisions and simultaneous thoracotomy.
Read the detailed description
This is a prospective follow-up study where the investigators aim to study patients who have undergone surgery with a muscle sparing, minimally invasive technique for unstable ribcage after trauma. The investigators plan on seeing the participants as out patients 6 months and 1 year after surgery. The results will be compared to results from a historical cohort with patients who participated in earlier studies with a different surgical method with large incisions and simultaneous thoracotomy. The investigators plan on including 50 patients since a preliminary analysis has suggested this should be enough to notice statistically significant differences between the groups.
- Being tested
- Minimally invasive surgical fixation of unstable rib cage, Large incision surgical fixation of unstable rib cage.
- Keywords
- Chest wall, Trauma, Minimally invasive, Surgery, Muscle sparing
- Medical subject headings
- Fractures, Bone, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgical fixation of unstable rib cageProcedure or surgery
Minimally invasive and muscle sparing surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes).
Large incision surgical fixation of unstable rib cage.Procedure or surgery
Surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes). Large non muscle sparing incision with simultaneous thoracotomy.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive | Patients who underwent surgery with a muscle sparing, minimally invasive technique for unstable chest wall after trauma. Receives: Procedure: Minimally invasive surgical fixation of unstable rib cage | |
| Historical control | Patients who underwent surgery with large incisions and simultaneous thoracotomy for unstable chest wall after trauma. Receives: Procedure: Large incision surgical fixation of unstable rib cage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital capacity of the lungs.
Vital capacity (VC) measured with spirometry.
Measured: One year after surgery.
Forced vital capacity of the lungs.
Forced vital capacity (VC) measured with spirometry.
Measured: One year after surgery.
Forced expiratory volume of the lungs.
Forced expiratory volume in 1 second (FEV1) measured with spirometry.
Measured: One year after surgery.
Forced expiratory volume percent of the lungs.
Forced expiratory volume in 1 second divided with forced vital capacity, measured with spirometry.
Measured: One year after surgery.
Peak expiratory flow of the lungs.
Peak expiratory flow measured with spirometry.
Measured: One year after surgery.
Secondary outcomes (7)
Disability
Degree of disability assessed with Disability Rating Index (DRI) scale ranging from 0-100 where higher scores indicate more disability.
Measured: Six months and one year after surgery.
Physical activity
Physical activity assessed with Grimby activity scale ranging from 1-6 where 6 indicates the highest level of activity.
Measured: Six months and one year after surgery.
Shoulder mobility
Shoulder mobility assessed with Boström index, a scale ranging from 5-30 for each shoulder where 30 represents the greatest range of movement.
Measured: Six months and one year after surgery.
Respiratory movement
Movement of chest wall during respiration measured with Respiratory Movement Measuring Instrument (RMMI).
Measured: Six months and one year after surgery.
Strength of respiratory muscles
Strength of respiratory muscles measured with Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP).
Measured: Six months and one year after surgery.
Quality of life EQ-5D-5L
Quality of life assessed with the EuroQol (European Quality of Life) Five Dimension Five Level Scale (EQ-5D-5L). A 5-dimensional scale in which each dimension has 5 levels where 1 represents the best outcome and 5 represents the worst outcome.
Measured: Six months and one year after surgery.
Radiological healing
Radiological signs of healing of the participants rib fractures assessed with CT scan. Fractures will be denoted as healed, partially healed or with no signs of healing.
Measured: One year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start15 Jan 2021
- Primary completion5 May 2022
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rib; Fracture, Multiple, With Flail ChestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Öberg Westin, Sahlgrenska University Hospital
- Investigators
- Erik Westin, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710602
- Sponsor's protocol ID
- FoU-274457
- Status last verified
- Nov 2023
- First submitted
- 18 Dec 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing data with other researchers will be considered by request.
Publications
Bemelman M, van Baal M, Yuan JZ, Leenen L. The Role of Minimally Invasive Plate Osteosynthesis in Rib Fixation: A Review. Korean J Thorac Cardiovasc Surg. 2016 Feb;49(1):1-8. doi: 10.5090/kjtcs.2016.49.1.1. Epub 2016 Feb 5.
PubMed 26889439Caragounis EC, Fagevik Olsen M, Pazooki D, Granhed H. Surgical treatment of multiple rib fractures and flail chest in trauma: a one-year follow-up study. World J Emerg Surg. 2016 Jun 14;11:27. doi: 10.1186/s13017-016-0085-2. eCollection 2016.
PubMed 27307787Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15.
PubMed 17670487Granhed HP, Pazooki D. A feasibility study of 60 consecutive patients operated for unstable thoracic cage. J Trauma Manag Outcomes. 2014 Dec 30;8(1):20. doi: 10.1186/s13032-014-0020-z. eCollection 2014.
PubMed 25642282Marasco SF, Davies AR, Cooper J, Varma D, Bennett V, Nevill R, Lee G, Bailey M, Fitzgerald M. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg. 2013 May;216(5):924-32. doi: 10.1016/j.jamcollsurg.2012.12.024. Epub 2013 Feb 13.
PubMed 23415550Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.
PubMed 11956391Westin EO, Olsen MF, Caragounis EC. Comparison of long-term outcome between muscle sparing and non-muscle sparing surgical techniques in rib plating. Eur J Trauma Emerg Surg. 2025 May 20;51(1):212. doi: 10.1007/s00068-025-02881-z.
PubMed 40392360
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Follow-up of Patients Treated With Muscle Sparing, Minimally Invasive Open Surgical Technique for Unstable Chest Wall After Trauma
- ClinicalTrials.gov ID
- NCT04710602
- Acronym / sponsor ID
- FoU-274457
- Keywords
- Chest wall, Trauma, Minimally invasive, Surgery, Muscle sparing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 14 Jan 2021 (actual)
- 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 study is to assess the outcome of a muscle sparing, minimally invasive open surgical technique for unstable ribcage injuries after trauma. The investigators will compare the results from the study participants to a historical cohort who were operated with a different surgical technique with large incisions and simultaneous thoracotomy.
Detailed description
This is a prospective follow-up study where the investigators aim to study patients who have undergone surgery with a muscle sparing, minimally invasive technique for unstable ribcage after trauma. The investigators plan on seeing the participants as out patients 6 months and 1 year after surgery. The results will be compared to results from a historical cohort with patients who participated in earlier studies with a different surgical method with large incisions and simultaneous thoracotomy. The investigators plan on including 50 patients since a preliminary analysis has suggested this should be enough to notice statistically significant differences between the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive | – | Procedure: Minimally invasive surgical fixation of unstable rib cagePatients who underwent surgery with a muscle sparing, minimally invasive technique for unstable chest wall after trauma. |
| Historical control | – | Procedure: Large incision surgical fixation of unstable rib cage.Patients who underwent surgery with large incisions and simultaneous thoracotomy for unstable chest wall after trauma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients surgically treated at our trauma ward for unstable chest wall due to trauma. Consecutive sampling.
Key inclusion criteria (1 listed)
- Patients with chest wall trauma who underwent surgical stabilisation for unstable chest wall using a minimally invasive, muscle sparing technique without thoracotomy or thoracoscopy no more than 6 months prior to inclusion.
Key exclusion criteria (3 listed)
- Severe head injury (Abbreviated Injury score (AIS) >3)
- Spinal injury
- Neurological or musculoskeletal disease affecting chest wall mobility
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 |
|---|---|---|
| Minimally invasive surgical fixation of unstable rib cageMinimally invasive and muscle sparing surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes). | Procedure or surgery | Minimally invasive |
| Large incision surgical fixation of unstable rib cage.Surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes). Large non muscle sparing incision with simultaneous thoracotomy. | Procedure or surgery | Historical control |
Primary outcome
Vital capacity of the lungs.
Time frame: One year after surgery.
Vital capacity (VC) measured with spirometry.
Forced vital capacity of the lungs.
Time frame: One year after surgery.
Forced vital capacity (VC) measured with spirometry.
Forced expiratory volume of the lungs.
Time frame: One year after surgery.
Forced expiratory volume in 1 second (FEV1) measured with spirometry.
Forced expiratory volume percent of the lungs.
Time frame: One year after surgery.
Forced expiratory volume in 1 second divided with forced vital capacity, measured with spirometry.
Peak expiratory flow of the lungs.
Time frame: One year after surgery.
Peak expiratory flow measured with spirometry.
7 secondary outcomes
Disability
Time frame: Six months and one year after surgery.
Physical activity
Time frame: Six months and one year after surgery.
Shoulder mobility
Time frame: Six months and one year after surgery.
Respiratory movement
Time frame: Six months and one year after surgery.
Strength of respiratory muscles
Time frame: Six months and one year after surgery.
Quality of life EQ-5D-5L
Time frame: Six months and one year after surgery.
Radiological healing
Time frame: One year after surgery.
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 1 May 2026.
- Background: PubMed 26889439Bemelman M, van Baal M, Yuan JZ, Leenen L. The Role of Minimally Invasive Plate Osteosynthesis in Rib Fixation: A Review. Korean J Thorac Cardiovasc Surg. 2016 Feb;49(1):1-8. doi: 10.5090/kjtcs.2016.49.1.1. Epub 2016 Feb 5.
- Background: PubMed 27307787Caragounis EC, Fagevik Olsen M, Pazooki D, Granhed H. Surgical treatment of multiple rib fractures and flail chest in trauma: a one-year follow-up study. World J Emerg Surg. 2016 Jun 14;11:27. doi: 10.1186/s13017-016-0085-2. eCollection 2016.
- Background: PubMed 17670487Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15.
- Background: PubMed 25642282Granhed HP, Pazooki D. A feasibility study of 60 consecutive patients operated for unstable thoracic cage. J Trauma Manag Outcomes. 2014 Dec 30;8(1):20. doi: 10.1186/s13032-014-0020-z. eCollection 2014.
- Background: PubMed 23415550Marasco SF, Davies AR, Cooper J, Varma D, Bennett V, Nevill R, Lee G, Bailey M, Fitzgerald M. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg. 2013 May;216(5):924-32. doi: 10.1016/j.jamcollsurg.2012.12.024. Epub 2013 Feb 13.
- Background: PubMed 11956391Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.
- Derived from this study: PubMed 40392360Westin EO, Olsen MF, Caragounis EC. Comparison of long-term outcome between muscle sparing and non-muscle sparing surgical techniques in rib plating. Eur J Trauma Emerg Surg. 2025 May 20;51(1):212. doi: 10.1007/s00068-025-02881-z.
- Individual participant dataSharing planned: No. Sharing data with other researchers will be considered by request.
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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.
Erik Westin, MD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib; Fracture, Multiple, With Flail Chest, run by Sahlgrenska University Hospital at 1 site 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 1 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Vital capacity of the lungs. (time frame: One year after surgery.). The study lists 5 primary outcomes in all. 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 NCT04710602, which also lists 7 linked publications.
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 1 May 2026.