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

August 17, 2026 updated by: National Taiwan University Hospital

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative assessment during the index SSRF procedure (immediately after fracture exposure and before plate fixation).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

October 29, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202508142DINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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