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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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