NCT Number: NCT07243808
Comparison of Mixed Reality and Ultrasound Localization Techniques for Surgical Stabilization of Rib Fractures
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.
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- Uncorrected coagulopathy.
- Known osteoporosis or pathologic fractures.
- Respiratory failure or hemodynamic instability requiring emergent surgery.
- Declines to participate or withdraws consent.
Treatment and study plan
Primary outcomes
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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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
National Taiwan University Hospital
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Nov 24, 2025
- Registry last updated
- Nov 24, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.