Surgical Stabilization of Rib FractureNCT07243808
Comparison of Mixed Reality and Ultrasound Localization Techniques for Surgical Stabilization of Rib Fractures
An observational study of Surgical Stabilization of Rib Fracture, run by National Taiwan University Hospital.
Trial summary
The goal of this observational study is to compare two localization methods used before surgical stabilization of rib fractures (SSRF): mixed reality (MR) and ultrasound-guided. Main Research Question Before SSRF, does MR help surgeons mark rib fracture locations more accurately (in centimeters) and faster than… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Stabilization of Rib Fracture
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 29 Oct 2027
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized adults 18-80 years with CT-confirmed ≥3 rib fractures who meet indications for surgical stabilization of rib fractures (SSRF) at participating thoracic surgery services. Participants are managed under routine care and, as part of preoperative planning, receive both mixed reality (MR) and ultrasound surface marking to enable within-subject accuracy comparisons. Enrollment is prospective (non-probability sampling). Key exclusions include uncorrected coagulopathy, known osteoporosis or pathologic fractures, and respiratory failure or hemodynamic instability requiring emergent surgery.
Who may be able to join
- Ages 18 to 80 years
- Computed tomography (CT) demonstrates ≥3 rib fractures, and the patient meets indications for surgical stabilization of rib fractures (SSRF).
- Able to understand the study and provide written informed consent.
Who cannot join
- Uncorrected coagulopathy.
- Known osteoporosis or pathologic fractures.
- Respiratory failure or hemodynamic instability requiring emergent surgery.
- Declines to participate or withdraws consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to compare two localization methods used before surgical stabilization of rib fractures (SSRF): mixed reality (MR) and ultrasound-guided.
Main Research Question Before SSRF, does MR help surgeons mark rib fracture locations more accurately (in centimeters) and faster than ultrasound-guided?
Participants After the study ends, all participants will keep follow-up at the thoracic surgery clinic. The team will record wound healing and pain scores for use in the observational study.
- Conditions
- Surgical Stabilization of Rib Fracture
- Keywords
- Ultrasound-guided localization, Mixed reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mixed reality and Ultrasound Guided Localization | This cohort includes participants undergoing surgical stabilization of rib fractures (SSRF) who, as part of routine preoperative planning, receive both mixed reality (MR) and ultrasound surface marking before surgery. Investigators do not assign exposure; both methods are performed within the same participant to enable a within-subject comparison of localization accuracy (cm). Outcomes are abstracted from the medical record and outpatient clinic follow-up through about 90 days after surgery (e.g., localization accuracy by method, localization time, operative time, incision length, complications, pain scores, length of stay, wound healing). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rib fracture localization accuracy (cm)
Definition: For each participant and each method (mixed reality [MR; OpVerse] and ultrasound), accuracy is the absolute linear distance (cm) between the preoperative skin mark and the intraoperatively identified center of the fracture after exposure.
Measurement: After skin incision and minimal soft-tissue dissection to expose the fracture line, the surgeon measures the shortest distance from the skin mark to the fracture center with a sterile ruler, recorded to 0.1 cm.
Analysis note: Accuracy will be summarized per method, and a within-subject difference (MR minus ultrasound) will be calculated.
Procedural note: If exposure is inadequate, the incision may be extended at the surgeon's discretion to safely perform SSRF; this does not change the measurement definition.
Measured: Intraoperative assessment during the index SSRF procedure (immediately after fracture exposure and before plate fixation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion29 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Surgical Stabilization of Rib FractureStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243808
- Sponsor's protocol ID
- 202508142DINC
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun DW, Zhai HX, Zhi JH, Chen KQ, Pang X, Xu M. Comparative efficacy of tunnel minimally invasive technique versus traditional open reduction and internal fixation for rib fractures. Eur J Med Res. 2025 Jul 9;30(1):603. doi: 10.1186/s40001-025-02864-1.
PubMed 40635080Zheng YA, Lee YC, Huang JY, Hsieh HY, Chen YS, Chiang XH, Han PH, Lin MW, Hsu HH, Hung YP, Chen JS. Enhancing three-dimensional anatomical understanding in complex thoracic surgery: a comparative study of OpVerse and Synapse 3D. Eur J Cardiothorac Surg. 2025 Mar 28;67(4):ezaf069. doi: 10.1093/ejcts/ezaf069.
PubMed 40163682Jung H, Raythatha J, Moghadam A, Jin G, Mao J, Hsu J, Kim J. RibMR - A Mixed Reality Visualization System for Rib Fracture Localization in Surgical Stabilization of Rib Fractures: Phantom, Preclinical, and Clinical Studies. J Imaging Inform Med. 2025 Oct;38(5):3279-3293. doi: 10.1007/s10278-024-01332-2. Epub 2024 Dec 20.
PubMed 39707113Magalhaes R, Oliveira A, Terroso D, Vilaca A, Veloso R, Marques A, Pereira J, Coelho L. Mixed Reality in the Operating Room: A Systematic Review. J Med Syst. 2024 Aug 15;48(1):76. doi: 10.1007/s10916-024-02095-7.
PubMed 39145896Lo HL, Lee JY, Lu CK, Lo OY, Lu CC, Tsai DL, Lin SY. Ultra minimally invasive surgical stabilization of Rib fractures (uMI-SSRF): reduction and fixation techniques to minimize the surgical wound. World J Emerg Surg. 2024 Nov 15;19(1):35. doi: 10.1186/s13017-024-00566-3.
PubMed 39548542Schots JP, Vissers YL, Hulsewe KW, Meesters B, Hustinx PA, Pijnenburg A, Siebenga J, de Loos ER. Addition of Video-Assisted Thoracoscopic Surgery to the Treatment of Flail Chest. Ann Thorac Surg. 2017 Mar;103(3):940-944. doi: 10.1016/j.athoracsur.2016.09.036. Epub 2016 Dec 7.
PubMed 27939010Martin TJ, Cao J, Benoit E, Kheirbek T. Optimizing surgical stabilization of rib fractures using intraoperative ultrasound localization. J Trauma Acute Care Surg. 2021 Aug 1;91(2):369-374. doi: 10.1097/TA.0000000000003262.
PubMed 33938512Fokin AA, Hus N, Wycech J, Rodriguez E, Puente I. Surgical Stabilization of Rib Fractures: Indications, Techniques, and Pitfalls. JBJS Essent Surg Tech. 2020 May 7;10(2):e0032. doi: 10.2106/JBJS.ST.19.00032. eCollection 2020 Apr-Jun.
PubMed 32944413Sermonesi 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 39425134Dehghan N, Nauth A, Schemitsch E, Vicente M, Jenkinson R, Kreder H, McKee M; Canadian Orthopaedic Trauma Society and the Unstable Chest Wall RCT Study Investigators. Operative vs Nonoperative Treatment of Acute Unstable Chest Wall Injuries: A Randomized Clinical Trial. JAMA Surg. 2022 Nov 1;157(11):983-990. doi: 10.1001/jamasurg.2022.4299.
PubMed 36129720Lian KH, Yang CC, Hu FC, Lin WY, Hsiao WL, Lin TH, Hu RH, Chen JS, Liao HC. Quality of life outcomes after surgical intervention in patients with multiple rib fractures: A prospective cohort study. Surgery. 2023 Apr;173(4):1066-1071. doi: 10.1016/j.surg.2022.12.006. Epub 2023 Jan 17.
PubMed 36658082Liu HY, Lin TH, Chen KC, Hsiao WL, Hu RH, Liao HC. Comparison between non-surgical and surgical management of rib fractures in major trauma patients without brain injuries. Am J Surg. 2023 Sep;226(3):350-355. doi: 10.1016/j.amjsurg.2023.05.025. Epub 2023 May 25.
PubMed 37263888Kao CC, Chen KC, Chiang XH, Chuang JH, Lu CW, Hsiao WL, Lin TH, Liao HC. Clinical outcomes of rib fracture stabilization and conservative treatment in a high-volume Asian trauma center: a propensity score-matched retrospective study. World J Emerg Surg. 2025 May 19;20(1):40. doi: 10.1186/s13017-025-00620-8.
PubMed 40390007Pieracci FM, Leasia K, Bauman Z, Eriksson EA, Lottenberg L, Majercik S, Powell L, Sarani B, Semon G, Thomas B, Zhao F, Dyke C, Doben AR. A multicenter, prospective, controlled clinical trial of surgical stabilization of rib fractures in patients with severe, nonflail fracture patterns (Chest Wall Injury Society NONFLAIL). J Trauma Acute Care Surg. 2020 Feb;88(2):249-257. doi: 10.1097/TA.0000000000002559.
PubMed 31804414
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mixed Reality and Ultrasound Localization Techniques for Surgical Stabilization of Rib Fractures
- ClinicalTrials.gov ID
- NCT07243808
- Acronym / sponsor ID
- 202508142DINC
- Conditions
- Surgical Stabilization of Rib Fracture
- Keywords
- Ultrasound-guided localization, Mixed reality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 29 Oct 2027 (estimated)
- First posted
- 24 Nov 2025 (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 observational study is to compare two localization methods used before surgical stabilization of rib fractures (SSRF): mixed reality (MR) and ultrasound-guided.
Main Research Question Before SSRF, does MR help surgeons mark rib fracture locations more accurately (in centimeters) and faster than ultrasound-guided?
Participants After the study ends, all participants will keep follow-up at the thoracic surgery clinic. The team will record wound healing and pain scores for use in the observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mixed reality and Ultrasound Guided Localization | – | –This cohort includes participants undergoing surgical stabilization of rib fractures (SSRF) who, as part of routine preoperative planning, receive both mixed reality (MR) and ultrasound surface marking before surgery. Investigators do not assign exposure; both methods are performed within the same participant to enable a within-subject comparison of localization accuracy (cm). Outcomes are abstracted from the medical record and outpatient clinic follow-up through about 90 days after surgery (e.g., localization accuracy by method, localization time, operative time, incision length, complications, pain scores, length of stay, wound healing). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adults 18-80 years with CT-confirmed ≥3 rib fractures who meet indications for surgical stabilization of rib fractures (SSRF) at participating thoracic surgery services. Participants are managed under routine care and, as part of preoperative planning, receive both mixed reality (MR) and ultrasound surface marking to enable within-subject accuracy comparisons. Enrollment is prospective (non-probability sampling). Key exclusions include uncorrected coagulopathy, known osteoporosis or pathologic fractures, and respiratory failure or hemodynamic instability requiring emergent surgery.
Key inclusion criteria (3 listed)
- Ages 18 to 80 years
- Computed tomography (CT) demonstrates ≥3 rib fractures, and the patient meets indications for surgical stabilization of rib fractures (SSRF).
- Able to understand the study and provide written informed consent.
Key exclusion criteria (4 listed)
- Uncorrected coagulopathy.
- Known osteoporosis or pathologic fractures.
- Respiratory failure or hemodynamic instability requiring emergent surgery.
- Declines to participate or withdraws consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rib fracture localization accuracy (cm)
Time frame: Intraoperative assessment during the index SSRF procedure (immediately after fracture exposure and before plate fixation).
Definition: For each participant and each method (mixed reality [MR; OpVerse] and ultrasound), accuracy is the absolute linear distance (cm) between the preoperative skin mark and the intraoperatively identified center of the fracture after exposure. Measurement: After skin incision and minimal soft-tissue dissection to expose the fracture line, the surgeon measures the shortest distance from the skin mark to the fracture center with a sterile ruler, recorded to 0.1 cm. Analysis note: Accuracy will be summarized per method, and a within-subject difference (MR minus ultrasound) will be calculated. Procedural note: If exposure is inadequate, the incision may be extended at the surgeon's discretion to safely perform SSRF; this does not change the measurement definition.
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 19 Aug 2026.
- Background: PubMed 40635080Sun DW, Zhai HX, Zhi JH, Chen KQ, Pang X, Xu M. Comparative efficacy of tunnel minimally invasive technique versus traditional open reduction and internal fixation for rib fractures. Eur J Med Res. 2025 Jul 9;30(1):603. doi: 10.1186/s40001-025-02864-1.
- Background: PubMed 40163682Zheng YA, Lee YC, Huang JY, Hsieh HY, Chen YS, Chiang XH, Han PH, Lin MW, Hsu HH, Hung YP, Chen JS. Enhancing three-dimensional anatomical understanding in complex thoracic surgery: a comparative study of OpVerse and Synapse 3D. Eur J Cardiothorac Surg. 2025 Mar 28;67(4):ezaf069. doi: 10.1093/ejcts/ezaf069.
- Background: PubMed 39707113Jung H, Raythatha J, Moghadam A, Jin G, Mao J, Hsu J, Kim J. RibMR - A Mixed Reality Visualization System for Rib Fracture Localization in Surgical Stabilization of Rib Fractures: Phantom, Preclinical, and Clinical Studies. J Imaging Inform Med. 2025 Oct;38(5):3279-3293. doi: 10.1007/s10278-024-01332-2. Epub 2024 Dec 20.
- Background: PubMed 39145896Magalhaes R, Oliveira A, Terroso D, Vilaca A, Veloso R, Marques A, Pereira J, Coelho L. Mixed Reality in the Operating Room: A Systematic Review. J Med Syst. 2024 Aug 15;48(1):76. doi: 10.1007/s10916-024-02095-7.
- Background: PubMed 39548542Lo HL, Lee JY, Lu CK, Lo OY, Lu CC, Tsai DL, Lin SY. Ultra minimally invasive surgical stabilization of Rib fractures (uMI-SSRF): reduction and fixation techniques to minimize the surgical wound. World J Emerg Surg. 2024 Nov 15;19(1):35. doi: 10.1186/s13017-024-00566-3.
- Background: PubMed 27939010Schots JP, Vissers YL, Hulsewe KW, Meesters B, Hustinx PA, Pijnenburg A, Siebenga J, de Loos ER. Addition of Video-Assisted Thoracoscopic Surgery to the Treatment of Flail Chest. Ann Thorac Surg. 2017 Mar;103(3):940-944. doi: 10.1016/j.athoracsur.2016.09.036. Epub 2016 Dec 7.
- Background: PubMed 33938512Martin TJ, Cao J, Benoit E, Kheirbek T. Optimizing surgical stabilization of rib fractures using intraoperative ultrasound localization. J Trauma Acute Care Surg. 2021 Aug 1;91(2):369-374. doi: 10.1097/TA.0000000000003262.
- Background: PubMed 32944413Fokin AA, Hus N, Wycech J, Rodriguez E, Puente I. Surgical Stabilization of Rib Fractures: Indications, Techniques, and Pitfalls. JBJS Essent Surg Tech. 2020 May 7;10(2):e0032. doi: 10.2106/JBJS.ST.19.00032. eCollection 2020 Apr-Jun.
- 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 36129720Dehghan N, Nauth A, Schemitsch E, Vicente M, Jenkinson R, Kreder H, McKee M; Canadian Orthopaedic Trauma Society and the Unstable Chest Wall RCT Study Investigators. Operative vs Nonoperative Treatment of Acute Unstable Chest Wall Injuries: A Randomized Clinical Trial. JAMA Surg. 2022 Nov 1;157(11):983-990. doi: 10.1001/jamasurg.2022.4299.
- Background: PubMed 36658082Lian KH, Yang CC, Hu FC, Lin WY, Hsiao WL, Lin TH, Hu RH, Chen JS, Liao HC. Quality of life outcomes after surgical intervention in patients with multiple rib fractures: A prospective cohort study. Surgery. 2023 Apr;173(4):1066-1071. doi: 10.1016/j.surg.2022.12.006. Epub 2023 Jan 17.
- Background: PubMed 37263888Liu HY, Lin TH, Chen KC, Hsiao WL, Hu RH, Liao HC. Comparison between non-surgical and surgical management of rib fractures in major trauma patients without brain injuries. Am J Surg. 2023 Sep;226(3):350-355. doi: 10.1016/j.amjsurg.2023.05.025. Epub 2023 May 25.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Stabilization of Rib Fracture, run by National Taiwan University Hospital.
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 3 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Hsien-Chi Liao, MD, MPH (+886-972651611, polarisliao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rib fracture localization accuracy (cm) (time frame: Intraoperative assessment during the index SSRF procedure (immediately after fracture exposure and before plate fixation).). 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 NCT07243808, which also lists 14 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 19 Aug 2026.