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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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

Other trials in Sweden

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.

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 groups in NCT07338656
Study groupRoleWhat they receive
Stabilization of two fractures per ribExperimentalNot described
Receives: Procedure: Surgical stabilization of two fractures per rib
Stabilization of one fracture per ribActive comparatorNot 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.

  1. 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)
  1. Postoperative pain (opioids)

    Pain assessed with opioid equivalents

    Measured: 1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.

  2. Postoperative pain (visual analogue scale)

    Pain assessed with a visual analogue scale.

    Measured: 1, 2, 3 days postoperatively and 1, 3, 12 months postoperatively.

  3. 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.

  4. Lung function with spirometry

    Lung function measured with spirometry. Predicted FVC will be the outcome measure.

    Measured: 1, 3 and 12 months after inclusion.

  5. Complications

    Postoperative complications such as implant dysfunction and osteomyelitis.

    Measured: Up to 12 months after inclusion.

  6. Postoperative symptoms

    Standardized questionnaire regarding postoperative symptoms such as tightness, shortness of breath.

    Measured: 1, 3 and 12 months after inclusion.

  7. Time in hospital

    Time spent in hospital after initial trauma

    Measured: From inclusion and up to 12 months after.

  8. Time in intensive care unit

    Time in intensive care unit after initial trauma.

    Measured: From inclusion and up to 12 months after.

  9. Time in ventilator

    Time in ventilator after initial trauma.

    Measured: From inclusion and up to 12 months after.

  10. 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.

  1. First posted14 Jan 2026
  2. Study start5 May 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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)
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 39425134
  • Marasco 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 25159250
  • Tichenor 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 37936903
  • Tay-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 36301075
  • Oberg 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 36925375
  • Xia 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 30542416
  • Fraser 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 26850079
  • Nowack 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 32845731
  • Zhang 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 33675706
  • Pieracci 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 30101174
  • Bauman 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 33778146
  • Schulz-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 27084543
  • Marasco 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 25624272
  • Gasparri 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 26816224
  • Granhed 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

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.

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