Rib Fracture MultipleNCT07338656
Surgery for Unstable Chest Wall Injuries - How Many Fractures Should be Fixed?
A study testing Surgical stabilization of two fractures per rib and Surgical stabilization of one fracture per rib. in people with Rib Fracture Multiple and Flail Chest, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The goal of this prospective, randomized study is to learn about the effects of two different surgical techniques for treating unstable chest wall injuries in adults. The main questions it aims to answer are: Does fixing two fractures per rib lead to better healing than fixing one fracture per rib in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fracture Multiple, Flail Chest
- What is being tested?
- Surgical stabilization of two fractures per rib and Surgical stabilization of one fracture per rib.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 5 May 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients scheduled for surgery of acute (≤7 days after trauma) unstable injuries in the chest wall at the Department of Surgery, Sahlgrenska University Hospital
- Both parts of the unstable segment must be accessible for surgery.
Who cannot join
- Patients with injuries resulting from CPR
- Patients with severe head injury (Head AIS>3)
- Patients with spinal injury
- Patients with neurological or musculoskeletal disease affecting chest wall mobility.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg
Erik Westin, MD, +46313426161, erik.westin@vgregion.se
About this study
The goal of this prospective, randomized study is to learn about the effects of two different surgical techniques for treating unstable chest wall injuries in adults. The main questions it aims to answer are:
Does fixing two fractures per rib lead to better healing than fixing one fracture per rib in patients with unstable chest injuries? Does the choice of surgical method affect lung function, pain, other symptoms, risk of pneumonia, or the risk of complications?
Read more
Participants will:
- Undergo surgery using either the standard method (fixing one fracture per rib) or an alternative method (fixing two fractures per rib), both using a muscle-sparing technique.
- Be followed up at 1, 3, and 12 months after surgery.
- Have CT scans at 3 months (and at 12 months if healing is incomplete) to assess bone healing.
- Be evaluated for lung function, pain, symptoms, and complications.
This study aims to provide new knowledge about which surgical method is best for unstable chest wall injuries, helping to improve treatment and recovery for these patients.
Read the detailed description
Surgical treatment of chest wall injuries is an area that has attracted increased interest in the research community. It is known that rib fractures, especially unstable injuries-so-called "flail chest"-lead to pain, increased risk of pneumonia, and in some cases, the need for ventilator support and intensive care. Surgical treatment has been shown to reduce the risk of these complications. There are several described surgical methods, including large, open surgery with or without simultaneous thoracotomy, and muscle-sparing open surgery that aims to minimize damage to surrounding tissue. Thoracoscopy is used both as the main fixation method and as an adjunct to open surgery to check for intrathoracic injuries and to clear the thoracic cavity of blood. There is also a described method where a working space is created between the chest wall and the overlying tissue, and surgery is performed using thoracoscopic techniques.
There are only a few studies comparing different surgical methods. It has been shown that a muscle-sparing method resulted in shorter stays in the intensive care unit and hospital, as well as less need for ventilator support. It has also been observed that a thoracoscopic technique led to shorter hospital stays than open surgery. Muscle-sparing surgery enables stabilization of the unstable chest wall segment through one or more smaller incisions where muscle fibers are preserved during fixation. It is not clearly established how many fractures should be fixed. It has been shown that a muscle-sparing technique is advantageous compared to a method with larger incisions and thoracotomy, even if fewer ribs are fixed in the muscle-sparing method. A retrospective study from 2014 showed that the more dorsal fracture row dislocates over time if only the anterior fractures are fixed. However, it is unclear whether this has any clinical significance in the long term. We have not found any prospective study comparing fixation of both fractures in an unstable chest wall segment with fixation of only one of the fractures.
The purpose of this study is to investigate whether fixation of both fractures in an unstable chest wall segment leads to better healing than fixation of only one of the fractures. We also want to examine whether lung function improves when more fractures are fixed, whether it leads to less pain for the patient, and what symptoms related to chest wall injuries patients experience in the long term.
The project is designed as a prospective, randomized study where we compare our current muscle-sparing surgical method with fixation of only one fracture in an unstable chest wall segment with a muscle-sparing method where at least two fractures on each rib (including cartilage) in an unstable segment are fixed.
Patients are asked to participate in the study. Upon consent, patients are randomized to surgery according to clinical routine with fixation of one of the fractures on each rib in the unstable segment or surgery of two or more fractures on each rib in the unstable segment. For the unstable segment to be considered fixed, no more than two fractures on consecutive ribs may be left unfixed. Both surgical methods are performed with minimally invasive muscle-sparing technique via one or more incisions. Randomization between the two groups will be 1:1 using sealed, opaque envelopes prepared by a person independent of the study and based on a digital randomization table.
CT scans of included patients are reviewed for the presence, location, and extent of fractures on the sternum, cartilage, and ribs, as well as the presence of pneumothorax and/or hemothorax, lung contusion, and lung laceration. Injuries are graded according to AIS, presence of flail segment, ISS, and NISS. Fractures are assessed for displacement. The surgeon decides on the indication for surgery according to current guidelines (flail segment) and documents which fractures are planned to be fixed.
Demographic data collected for included patients: age, sex, height, weight, BMI, smoking status, comorbidities (COPD, asthma, pulmonary emphysema, diabetes mellitus).
The following data are collected during the hospital stay: number and length of incisions, knife time, time in hospital, time in intensive care unit and on ventilator, incidence of pneumonia, degree of pain measured with visual analogue scale (VAS), opioid equivalents, and a graphical representation on postoperative days 1, 2, and 3.
The following data are collected at follow-up visits at 1, 3, and 12 months: Radiological healing is examined with CT after 3 months. If complete radiological healing of the chest wall is lacking, a new CT is performed after 12 months. Presence of chest wall deformity and synostosis between ribs is noted. At all visits, lung function is studied with spirometry, chronic complications such as implant dysfunction and osteomyelitis, as well as pain with VAS, opioid equivalents, and a graphical representation. Patients also complete a standardized questionnaire about their symptoms.
Prospective, randomized methodological studies for fixation of rib fractures are currently lacking. It is important for method development to study the outcomes of different surgical techniques, and increased understanding of their advantages and disadvantages can greatly benefit future patients with rib fractures where surgery is indicated. The surgical technique used can affect recovery time, postoperative pain, function, and quality of life.
- Conditions
- Rib Fracture Multiple, Flail Chest
- Being tested
- Surgical stabilization of two fractures per rib, Surgical stabilization of one fracture per rib.
- Keywords
- Rib Fractures, Flail Chest, Traumatology, Comparative Study
- Medical subject headings
- Flail Chest, Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical stabilization of two fractures per ribProcedure or surgery
Surgical stabilization of two fractures per rib in an unstable chest wall segment.
Surgical stabilization of one fracture per rib.Procedure or surgery
Surgical stabilization of one fracture per rib in an unstable chest wall segment.
| Study group | Role | What they receive |
|---|---|---|
| Stabilization of two fractures per rib | Experimental | Not described Receives: Procedure: Surgical stabilization of two fractures per rib |
| Stabilization of one fracture per rib | Active comparator | Not described Receives: Procedure: Surgical stabilization of one fracture per rib. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological healing
Fracture healing on CT described as "union", "non-union" or "partial union" by radiologist.
Measured: 3 months after inclusion, 12 months after inclusion if not healed after 3 months.
Secondary outcomes (10)
Postoperative pain (opioids)
Pain assessed with opioid equivalents
Measured: 1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.
Postoperative pain (visual analogue scale)
Pain assessed with a visual analogue scale.
Measured: 1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.
Postoperative pain (graphical representation)
Pain assessed with a graphical representation of the human body where areas of pain can be indicated by the participant.
Measured: 1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.
Lung function with spirometry
Lung function measured with spirometry. Predicted FVC will be the outcome measure.
Measured: 1, 3 and 12 months after inclusion.
Complications
Postoperative complications such as implant dysfunction and osteomyelitis.
Measured: Up to 12 months after inclusion.
Postoperative symptoms
Standardized questionnaire regarding postoperative symptoms such as tightness, shortness of breath.
Measured: 1, 3 and 12 months after inclusion.
Time in hospital
Time spent in hospital after initial trauma
Measured: From inclusion and up to 12 months after.
Time in intensive care unit
Time in intensive care unit after initial trauma.
Measured: From inclusion and up to 12 months after.
Time in ventilator
Time in ventilator after initial trauma.
Measured: From inclusion and up to 12 months after.
Incidence of pneumonia
Incidence of pneumonia defined as radiological imaging consistent with pneumonia combined with typical symptoms (cough, shortness of breath, fever) or positive sputum culture.
Measured: Up to 30 days after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start5 May 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Rib Fracture MultipleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
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
- Eva-Corina Caragounis, Ph.D, Ass. Prof, Study director, Institution of Clinical Sciences, Sahlgrenska Academy, Gothenburg University. Department of Surgery, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338656
- Sponsor's protocol ID
- 286203
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sermonesi G, Bertelli R, Pieracci FM, Balogh ZJ, Coimbra R, Galante JM, Hecker A, Weber D, Bauman ZM, Kartiko S, Patel B, Whitbeck SS, White TW, Harrell KN, Perrina D, Rampini A, Tian B, Amico F, Beka SG, Bonavina L, Ceresoli M, Cobianchi L, Coccolini F, Cui Y, Dal Mas F, De Simone B, Di Carlo I, Di Saverio S, Dogjani A, Fette A, Fraga GP, Gomes CA, Khan JS, Kirkpatrick AW, Kruger VF, Leppaniemi A, Litvin A, Mingoli A, Navarro DC, Passera E, Pisano M, Podda M, Russo E, Sakakushev B, Santonastaso D, Sartelli M, Shelat VG, Tan E, Wani I, Abu-Zidan FM, Biffl WL, Civil I, Latifi R, Marzi I, Picetti E, Pikoulis M, Agnoletti V, Bravi F, Vallicelli C, Ansaloni L, Moore EE, Catena F. Surgical stabilization of rib fractures (SSRF): the WSES and CWIS position paper. World J Emerg Surg. 2024 Oct 18;19(1):33. doi: 10.1186/s13017-024-00559-2.
PubMed 39425134Marasco S, Liew S, Edwards E, Varma D, Summerhayes R. Analysis of bone healing in flail chest injury: do we need to fix both fractures per rib? J Trauma Acute Care Surg. 2014 Sep;77(3):452-8. doi: 10.1097/TA.0000000000000375.
PubMed 25159250Tichenor M, Reparaz LB, Watson C, Reeves J, Prest P, Fitzgerald M, Patel N, Tan X, Hessey J. Intrathoracic plates versus extrathoracic plates: a comparison of postoperative pain in surgical stabilization of rib fracture technique. Trauma Surg Acute Care Open. 2023 Nov 3;8(1):e001201. doi: 10.1136/tsaco-2023-001201. eCollection 2023.
PubMed 37936903Tay-Lasso E, Alaniz L, Grant W, Hovis G, Frank M, Kincaid C, Brynn S, Pieracci FM, Nahmias J, Barrios C, Rockne W, Chin T, Swentek L, Schubl SD. Prospective single-center paradigm shift of surgical stabilization of rib fractures with decreased length of stay and operative time with an intrathoracic approach. J Trauma Acute Care Surg. 2023 Apr 1;94(4):567-572. doi: 10.1097/TA.0000000000003811. Epub 2022 Oct 25.
PubMed 36301075Oberg Westin E, Fagevik Olsen M, Ortenwall P, Caragounis EC. Retrospective comparison of operative technique for chest wall injuries. Injury. 2023 Jun;54(6):1595-1600. doi: 10.1016/j.injury.2023.03.012. Epub 2023 Mar 10.
PubMed 36925375Xia H, Zhu P, Li J, Zhu D, Sun Z, Deng L, Zhang Y, Wang D. Thoracoscope combined with internal support system of chest wall in open reduction and internal fixation for multiple rib fractures. Exp Ther Med. 2018 Dec;16(6):4650-4654. doi: 10.3892/etm.2018.6817. Epub 2018 Oct 1.
PubMed 30542416Fraser SF, Tan C, Kuppusamy MK, Gukop P, Hunt IJ. The role of a video-assisted thoracic approach for rib fixation. Eur J Trauma Emerg Surg. 2017 Apr;43(2):185-190. doi: 10.1007/s00068-016-0641-1. Epub 2016 Feb 5.
PubMed 26850079Nowack T, Nonnemacher C, Christie DB. Video-Assisted Thoracoscopic Surgery as an Adjunct to Rib Fixation. Am Surg. 2022 Jun;88(6):1338-1340. doi: 10.1177/0003134820943642. Epub 2020 Aug 26. No abstract available.
PubMed 32845731Zhang J, Hong Q, Mo X, Ma C. Complete Video-assisted Thoracoscopic Surgery for Rib Fractures: Series of 35 Cases. Ann Thorac Surg. 2022 Feb;113(2):452-458. doi: 10.1016/j.athoracsur.2021.01.065. Epub 2021 Mar 3.
PubMed 33675706Pieracci FM, Johnson JL, Stovall RT, Jurkovich GJ. Completely thoracoscopic, intra-pleural reduction and fixation of severe rib fractures. Trauma Case Rep. 2015 Nov 4;1(5-8):39-43. doi: 10.1016/j.tcr.2015.10.001. eCollection 2015 Oct. No abstract available.
PubMed 30101174Bauman ZM, Beard R, Cemaj S. When less is more: A minimally invasive, intrathoracic approach to surgical stabilization of rib fractures. Trauma Case Rep. 2021 Mar 11;32:100452. doi: 10.1016/j.tcr.2021.100452. eCollection 2021 Apr.
PubMed 33778146Schulz-Drost S, Grupp S, Pachowsky M, Oppel P, Krinner S, Mauerer A, Hennig FF, Langenbach A. Stabilization of flail chest injuries: minimized approach techniques to treat the core of instability. Eur J Trauma Emerg Surg. 2017 Apr;43(2):169-178. doi: 10.1007/s00068-016-0664-7. Epub 2016 Mar 22.
PubMed 27084543Marasco S, Saxena P. Surgical rib fixation - technical aspects. Injury. 2015 May;46(5):929-32. doi: 10.1016/j.injury.2014.12.021. Epub 2015 Jan 10.
PubMed 25624272Gasparri MG, Tisol WB, Haasler GB. Rib stabilization: lessons learned. Eur J Trauma Emerg Surg. 2010 Oct;36(5):435-40. doi: 10.1007/s00068-010-0048-3. Epub 2010 Sep 24.
PubMed 26816224Granhed 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 25642282
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery for Unstable Chest Wall Injuries - How Many Fractures Should be Fixed?
- ClinicalTrials.gov ID
- NCT07338656
- Acronym / sponsor ID
- 286203
- Conditions
- Rib Fracture Multiple, Flail Chest
- Keywords
- Rib Fractures, Flail Chest, Traumatology, Comparative Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Jan 2026 (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 goal of this prospective, randomized study is to learn about the effects of two different surgical techniques for treating unstable chest wall injuries in adults. The main questions it aims to answer are:
Does fixing two fractures per rib lead to better healing than fixing one fracture per rib in patients with unstable chest injuries? Does the choice of surgical method affect lung function, pain, other symptoms, risk of pneumonia, or the risk of complications?
Participants will:
- Undergo surgery using either the standard method (fixing one fracture per rib) or an alternative method (fixing two fractures per rib), both using a muscle-sparing technique.
- Be followed up at 1, 3, and 12 months after surgery.
- Have CT scans at 3 months (and at 12 months if healing is incomplete) to assess bone healing.
- Be evaluated for lung function, pain, symptoms, and complications.
This study aims to provide new knowledge about which surgical method is best for unstable chest wall injuries, helping to improve treatment and recovery for these patients.
Detailed description
Surgical treatment of chest wall injuries is an area that has attracted increased interest in the research community. It is known that rib fractures, especially unstable injuries-so-called "flail chest"-lead to pain, increased risk of pneumonia, and in some cases, the need for ventilator support and intensive care. Surgical treatment has been shown to reduce the risk of these complications. There are several described surgical methods, including large, open surgery with or without simultaneous thoracotomy, and muscle-sparing open surgery that aims to minimize damage to surrounding tissue. Thoracoscopy is used both as the main fixation method and as an adjunct to open surgery to check for intrathoracic injuries and to clear the thoracic cavity of blood. There is also a described method where a working space is created between the chest wall and the overlying tissue, and surgery is performed using thoracoscopic techniques.
There are only a few studies comparing different surgical methods. It has been shown that a muscle-sparing method resulted in shorter stays in the intensive care unit and hospital, as well as less need for ventilator support. It has also been observed that a thoracoscopic technique led to shorter hospital stays than open surgery. Muscle-sparing surgery enables stabilization of the unstable chest wall segment through one or more smaller incisions where muscle fibers are preserved during fixation. It is not clearly established how many fractures should be fixed. It has been shown that a muscle-sparing technique is advantageous compared to a method with larger incisions and thoracotomy, even if fewer ribs are fixed in the muscle-sparing method. A retrospective study from 2014 showed that the more dorsal fracture row dislocates over time if only the anterior fractures are fixed. However, it is unclear whether this has any clinical significance in the long term. We have not found any prospective study comparing fixation of both fractures in an unstable chest wall segment with fixation of only one of the fractures.
The purpose of this study is to investigate whether fixation of both fractures in an unstable chest wall segment leads to better healing than fixation of only one of the fractures. We also want to examine whether lung function improves when more fractures are fixed, whether it leads to less pain for the patient, and what symptoms related to chest wall injuries patients experience in the long term.
The project is designed as a prospective, randomized study where we compare our current muscle-sparing surgical method with fixation of only one fracture in an unstable chest wall segment with a muscle-sparing method where at least two fractures on each rib (including cartilage) in an unstable segment are fixed.
Patients are asked to participate in the study. Upon consent, patients are randomized to surgery according to clinical routine with fixation of one of the fractures on each rib in the unstable segment or surgery of two or more fractures on each rib in the unstable segment. For the unstable segment to be considered fixed, no more than two fractures on consecutive ribs may be left unfixed. Both surgical methods are performed with minimally invasive muscle-sparing technique via one or more incisions. Randomization between the two groups will be 1:1 using sealed, opaque envelopes prepared by a person independent of the study and based on a digital randomization table.
CT scans of included patients are reviewed for the presence, location, and extent of fractures on the sternum, cartilage, and ribs, as well as the presence of pneumothorax and/or hemothorax, lung contusion, and lung laceration. Injuries are graded according to AIS, presence of flail segment, ISS, and NISS. Fractures are assessed for displacement. The surgeon decides on the indication for surgery according to current guidelines (flail segment) and documents which fractures are planned to be fixed.
Demographic data collected for included patients: age, sex, height, weight, BMI, smoking status, comorbidities (COPD, asthma, pulmonary emphysema, diabetes mellitus).
The following data are collected during the hospital stay: number and length of incisions, knife time, time in hospital, time in intensive care unit and on ventilator, incidence of pneumonia, degree of pain measured with visual analogue scale (VAS), opioid equivalents, and a graphical representation on postoperative days 1, 2, and 3.
The following data are collected at follow-up visits at 1, 3, and 12 months: Radiological healing is examined with CT after 3 months. If complete radiological healing of the chest wall is lacking, a new CT is performed after 12 months. Presence of chest wall deformity and synostosis between ribs is noted. At all visits, lung function is studied with spirometry, chronic complications such as implant dysfunction and osteomyelitis, as well as pain with VAS, opioid equivalents, and a graphical representation. Patients also complete a standardized questionnaire about their symptoms.
Prospective, randomized methodological studies for fixation of rib fractures are currently lacking. It is important for method development to study the outcomes of different surgical techniques, and increased understanding of their advantages and disadvantages can greatly benefit future patients with rib fractures where surgery is indicated. The surgical technique used can affect recovery time, postoperative pain, function, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization of two fractures per rib | Experimental | Procedure: Surgical stabilization of two fractures per rib |
| Stabilization of one fracture per rib | Active comparator | Procedure: Surgical stabilization of one fracture per rib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for surgery of acute (≤7 days after trauma) unstable injuries in the chest wall at the Department of Surgery, Sahlgrenska University Hospital
- Both parts of the unstable segment must be accessible for surgery.
Key exclusion criteria (4 listed)
- Patients with injuries resulting from CPR
- Patients with severe head injury (Head AIS>3)
- Patients with spinal injury
- Patients with 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 |
|---|---|---|
| Surgical stabilization of two fractures per ribSurgical stabilization of two fractures per rib in an unstable chest wall segment. | Procedure or surgery | Stabilization of two fractures per rib |
| Surgical stabilization of one fracture per rib.Surgical stabilization of one fracture per rib in an unstable chest wall segment. | Procedure or surgery | Stabilization of one fracture per rib |
Primary outcome
Radiological healing
Time frame: 3 months after inclusion, 12 months after inclusion if not healed after 3 months.
Fracture healing on CT described as "union", "non-union" or "partial union" by radiologist.
10 secondary outcomes
Postoperative pain (opioids)
Time frame: 1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.
Postoperative pain (visual analogue scale)
Time frame: 1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.
Postoperative pain (graphical representation)
Time frame: 1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.
Lung function with spirometry
Time frame: 1, 3 and 12 months after inclusion.
Complications
Time frame: Up to 12 months after inclusion.
Postoperative symptoms
Time frame: 1, 3 and 12 months after inclusion.
Time in hospital
Time frame: From inclusion and up to 12 months after.
Time in intensive care unit
Time frame: From inclusion and up to 12 months after.
Time in ventilator
Time frame: From inclusion and up to 12 months after.
Incidence of pneumonia
Time frame: Up to 30 days after inclusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 39425134Sermonesi G, Bertelli R, Pieracci FM, Balogh ZJ, Coimbra R, Galante JM, Hecker A, Weber D, Bauman ZM, Kartiko S, Patel B, Whitbeck SS, White TW, Harrell KN, Perrina D, Rampini A, Tian B, Amico F, Beka SG, Bonavina L, Ceresoli M, Cobianchi L, Coccolini F, Cui Y, Dal Mas F, De Simone B, Di Carlo I, Di Saverio S, Dogjani A, Fette A, Fraga GP, Gomes CA, Khan JS, Kirkpatrick AW, Kruger VF, Leppaniemi A, Litvin A, Mingoli A, Navarro DC, Passera E, Pisano M, Podda M, Russo E, Sakakushev B, Santonastaso D, Sartelli M, Shelat VG, Tan E, Wani I, Abu-Zidan FM, Biffl WL, Civil I, Latifi R, Marzi I, Picetti E, Pikoulis M, Agnoletti V, Bravi F, Vallicelli C, Ansaloni L, Moore EE, Catena F. Surgical stabilization of rib fractures (SSRF): the WSES and CWIS position paper. World J Emerg Surg. 2024 Oct 18;19(1):33. doi: 10.1186/s13017-024-00559-2.
- Background: PubMed 25159250Marasco S, Liew S, Edwards E, Varma D, Summerhayes R. Analysis of bone healing in flail chest injury: do we need to fix both fractures per rib? J Trauma Acute Care Surg. 2014 Sep;77(3):452-8. doi: 10.1097/TA.0000000000000375.
- Background: PubMed 37936903Tichenor M, Reparaz LB, Watson C, Reeves J, Prest P, Fitzgerald M, Patel N, Tan X, Hessey J. Intrathoracic plates versus extrathoracic plates: a comparison of postoperative pain in surgical stabilization of rib fracture technique. Trauma Surg Acute Care Open. 2023 Nov 3;8(1):e001201. doi: 10.1136/tsaco-2023-001201. eCollection 2023.
- Background: PubMed 36301075Tay-Lasso E, Alaniz L, Grant W, Hovis G, Frank M, Kincaid C, Brynn S, Pieracci FM, Nahmias J, Barrios C, Rockne W, Chin T, Swentek L, Schubl SD. Prospective single-center paradigm shift of surgical stabilization of rib fractures with decreased length of stay and operative time with an intrathoracic approach. J Trauma Acute Care Surg. 2023 Apr 1;94(4):567-572. doi: 10.1097/TA.0000000000003811. Epub 2022 Oct 25.
- Background: PubMed 36925375Oberg Westin E, Fagevik Olsen M, Ortenwall P, Caragounis EC. Retrospective comparison of operative technique for chest wall injuries. Injury. 2023 Jun;54(6):1595-1600. doi: 10.1016/j.injury.2023.03.012. Epub 2023 Mar 10.
- Background: PubMed 30542416Xia H, Zhu P, Li J, Zhu D, Sun Z, Deng L, Zhang Y, Wang D. Thoracoscope combined with internal support system of chest wall in open reduction and internal fixation for multiple rib fractures. Exp Ther Med. 2018 Dec;16(6):4650-4654. doi: 10.3892/etm.2018.6817. Epub 2018 Oct 1.
- Background: PubMed 26850079Fraser SF, Tan C, Kuppusamy MK, Gukop P, Hunt IJ. The role of a video-assisted thoracic approach for rib fixation. Eur J Trauma Emerg Surg. 2017 Apr;43(2):185-190. doi: 10.1007/s00068-016-0641-1. Epub 2016 Feb 5.
- Background: PubMed 32845731Nowack T, Nonnemacher C, Christie DB. Video-Assisted Thoracoscopic Surgery as an Adjunct to Rib Fixation. Am Surg. 2022 Jun;88(6):1338-1340. doi: 10.1177/0003134820943642. Epub 2020 Aug 26. No abstract available.
- Background: PubMed 33675706Zhang J, Hong Q, Mo X, Ma C. Complete Video-assisted Thoracoscopic Surgery for Rib Fractures: Series of 35 Cases. Ann Thorac Surg. 2022 Feb;113(2):452-458. doi: 10.1016/j.athoracsur.2021.01.065. Epub 2021 Mar 3.
- Background: PubMed 30101174Pieracci FM, Johnson JL, Stovall RT, Jurkovich GJ. Completely thoracoscopic, intra-pleural reduction and fixation of severe rib fractures. Trauma Case Rep. 2015 Nov 4;1(5-8):39-43. doi: 10.1016/j.tcr.2015.10.001. eCollection 2015 Oct. No abstract available.
- Background: PubMed 33778146Bauman ZM, Beard R, Cemaj S. When less is more: A minimally invasive, intrathoracic approach to surgical stabilization of rib fractures. Trauma Case Rep. 2021 Mar 11;32:100452. doi: 10.1016/j.tcr.2021.100452. eCollection 2021 Apr.
- Background: PubMed 27084543Schulz-Drost S, Grupp S, Pachowsky M, Oppel P, Krinner S, Mauerer A, Hennig FF, Langenbach A. Stabilization of flail chest injuries: minimized approach techniques to treat the core of instability. Eur J Trauma Emerg Surg. 2017 Apr;43(2):169-178. doi: 10.1007/s00068-016-0664-7. Epub 2016 Mar 22.
- Individual participant dataSharing planned: Undecided
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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.
Eva-Corina Caragounis, Ph.D, Ass. Prof study director
Institution of Clinical Sciences, Sahlgrenska Academy, Gothenburg University. Department of Surgery, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical stabilization of two fractures per rib and Surgical stabilization of one fracture per rib. in people with Rib Fracture Multiple and 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik Westin, MD (+46313426161, erik.westin@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological healing (time frame: 3 months after inclusion, 12 months after inclusion if not healed after 3 months.). 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 NCT07338656, which also lists 23 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 28 Apr 2026.