Comparison of Mixed Reality and Ultrasound Localization Techniques for Surgical Stabilization of Rib Fractures

NCT ID: NCT07243808

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-10-29

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Stabilization of Rib Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Ages 18 to 80 years
2. Computed tomography (CT) demonstrates ≥3 rib fractures, and the patient meets indications for surgical stabilization of rib fractures (SSRF).
3. Able to understand the study and provide written informed consent.

Exclusion Criteria

1. Uncorrected coagulopathy.
2. Known osteoporosis or pathologic fractures.
3. Respiratory failure or hemodynamic instability requiring emergent surgery.
4. Declines to participate or withdraws consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Hsien-Chi Liao, MD, MPH

Role: CONTACT

+886-972651611

References

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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.

Reference Type BACKGROUND
PMID: 40635080 (View on PubMed)

Zheng 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.

Reference Type BACKGROUND
PMID: 40163682 (View on PubMed)

Jung 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. 2024 Dec 20. doi: 10.1007/s10278-024-01332-2. Online ahead of print.

Reference Type BACKGROUND
PMID: 39707113 (View on PubMed)

Magalhaes 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.

Reference Type BACKGROUND
PMID: 39145896 (View on PubMed)

Lo 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.

Reference Type BACKGROUND
PMID: 39548542 (View on PubMed)

Schots 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.

Reference Type BACKGROUND
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Martin 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.

Reference Type BACKGROUND
PMID: 33938512 (View on PubMed)

Fokin 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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 39425134 (View on PubMed)

Dehghan 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.

Reference Type BACKGROUND
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Lian 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.

Reference Type BACKGROUND
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Liu 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.

Reference Type BACKGROUND
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Kao 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.

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Reference Type BACKGROUND
PMID: 31804414 (View on PubMed)

Other Identifiers

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202508142DINC

Identifier Type: -

Identifier Source: org_study_id

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