Bone Injuries, Muscle Injuries, Tendon Injuries
Conditions
Brief summary
Determine if volume imaging can diagnose bone, ligament, muscle injuries.
Detailed description
The investigators are attempting to determine if Volume imaging (a new type of ultrasound imaging)can accurately diagnose injuries of the muscle ligaments, tendons and bones when compared to conventional ultrasound imaging.
Interventions
PROCEDUREUltrasound Scan
Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician.
DEVICEUltrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).
The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to x-ray the muscle and tendon injuries.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Must be scheduled to have a musculoskeletal (bone, ligament, muscle, tendon) ultrasound performed as part of their routine clinical care.
Exclusion criteria
* Unable to lie flat on ultrasound table. * Subjects under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging | Up to 13 minutes | Both ultrasound and volume imaging scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. It took 5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan. |
Countries
United States
Participant flow
Recruitment details
Patients who are referred for an ultrasound of the extremity will be asked to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Volume Imaging Scan New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.
Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.
Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Volume Imaging Scan |
|---|---|
| Age, Continuous | 25 years |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging
Both ultrasound and volume imaging scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. It took 5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan.
Time frame: Up to 13 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Volume Imaging Scan | Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging | NA percent correlation |