Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects
Study Details
Study Description
Brief Summary
The purpose of this study is to examine whether ultrasound bone strength device (Model Number: Oste-scan 500A) is effective and safe in measuring calcaneal bone strength index of human subjects, compared with a listed, similar device (Model Number: SONOST3000).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This study adopt a method of multicenter, open-labeled, self-paired design. Each subject will be randomly assigned to two different detective sequence groups. In one group, the investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device firstly and then by control device. In another group, the investigators will detect the same calcaneus of each subject by control ultrasound bone strength device firstly and then by experimental device. Experimental ultrasound bone strength device is developed by Wuxi Huajian Hengchuang Medical Equipment Science and Technology Co., Ltd.. This device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G). Control ultrasound bone strength device which has same clinical indications and action mechanism with the experimental one, is manufactured by Osteosys Co., Ltd.. This device's model number is SONOST3000.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Oste-scan 500A-SONOST3000 In this group, the investigators will measure calcaneal bone strength index of each subject by experimental device firstly and then by control device. |
Device: Oste-scan 500A
The investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device. Experimental ultrasound bone strength device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G).
Device: SONOST3000
The investigators will detect the same calcaneus of each subject by control ultrasound bone strength device. Control ultrasound bone strength device's model number is SONOST3000.
|
| Experimental: SONOST3000-Oste-scan 500A In this group, the investigators will measure calcaneal bone strength index of each subject by control device firstly and then by experimental device. |
Device: Oste-scan 500A
The investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device. Experimental ultrasound bone strength device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G).
Device: SONOST3000
The investigators will detect the same calcaneus of each subject by control ultrasound bone strength device. Control ultrasound bone strength device's model number is SONOST3000.
|
Outcome Measures
Primary Outcome Measures
- the consistent rate of bone mineral density diagnosis [0-24 hours after detection]
Calculating the consistent rate with data measured by two devices to evaluate the consistent rate of bone mineral density diagnosis.
Secondary Outcome Measures
- the accuracy of speed of sound(SOS) [After detection]
SOS values measured by two devices will be tested by Paired T Test and Wilcoxon Signed Rank Test to evaluate the difference. In addition, calculating correlation coefficient and concordance correlation coefficient of SOS values measured by two devices to evaluate correlation and concordance of two devices.
- the accuracy of broadband ultrasound attenuation(BUA), stiffness(SI), T-scores and Z-scores [After detection]
Plotting monotonicity curves of BUA values, SI values, T-scores and Z-scores of two devices to evaluate the correlation of two devices.
- the using performance evaluation index of the device, including function, stability and convenience [during detection and 0-24 hours after detection]
Evaluating the using performance evaluation index of the device, including function, stability and convenience.
- vital signs, including respiration, heart rate, blood pressure and temperature [before detection, during detection and 0-24 hours after detection]
Vital signs, including respiration, heart rate, blood pressure and temperature will be observed and recorded before detection, during detection and 0-24 hours after detection.
- clinical symptoms [before detection, during detection and 0-24 hours after detection]
Clinical symptoms will be observed and recorded before detection, during detection and 0-24 hours after detection.
- skin allergy caused by the device [before detection, during detection and 0-24 hours after detection]
Skin allergy caused by the device will be observed and recorded before detection, during detection and 0-24 hours after detection.
- the number of participants with adverse events [in the entire trial]
Adverse events appeared in the entire trial will be recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject who need to measure calcaneal bone strength index.
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Subject is a male or female subject 20-80 years of age.
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Subject is willing and able to provide signed and dated written informed consent form.
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Subject whose compliance is good and can cooperate to complete the clinical trial.
Exclusion Criteria:
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Subject whose heel skin fester or defect.
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Subject has a history of allergic reactions to ultrasonic coupling agent.
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Subject who is not cooperative obviously or nervous extremely.
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Pregnant or lactating females.
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Subject has a mental disease, without self-control.
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Subject has participated in other clinical trial within a month.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China | 210011 |
Sponsors and Collaborators
- The Second Hospital of Nanjing Medical University
Investigators
- Principal Investigator: Huijie Zhang, Doctor, Office Director of Clinical Trial Institution
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HJHC-YLQX2016001