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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oste-scan 500A-SONOST3000 | Experimental | In this group, the investigators will measure calcaneal bone strength index of each subject by experimental device firstly and then by control device. |
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| SONOST3000-Oste-scan 500A | Experimental | In this group, the investigators will measure calcaneal bone strength index of each subject by control device firstly and then by experimental device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oste-scan 500A | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| the consistent rate of bone mineral density diagnosis | Calculating the consistent rate with data measured by two devices to evaluate the consistent rate of bone mineral density diagnosis. | 0-24 hours after detection |
| Measure | Description | Time Frame |
|---|---|---|
| the accuracy of speed of sound(SOS) | 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. | After detection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huijie Zhang, Doctor | Office Director of Clinical Trial Institution | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 27, 2018 | |
| Unrelease | Jul 4, 2018 | |
| Release | Jul 4, 2018 |
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| SONOST3000 | Device | 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. |
|
| the accuracy of broadband ultrasound attenuation(BUA), stiffness(SI), T-scores and Z-scores | Plotting monotonicity curves of BUA values, SI values, T-scores and Z-scores of two devices to evaluate the correlation of two devices. | After detection |
| the using performance evaluation index of the device, including function, stability and convenience | Evaluating the using performance evaluation index of the device, including function, stability and convenience. | during detection and 0-24 hours after detection |
| vital signs, including respiration, heart rate, blood pressure and temperature | 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. | before detection, during detection and 0-24 hours after detection |
| clinical symptoms | Clinical symptoms will be observed and recorded before detection, during detection and 0-24 hours after detection. | before detection, during detection and 0-24 hours after detection |
| skin allergy caused by the device | Skin allergy caused by the device will be observed and recorded before detection, during detection and 0-24 hours after detection. | before detection, during detection and 0-24 hours after detection |
| the number of participants with adverse events | Adverse events appeared in the entire trial will be recorded. | in the entire trial |
| Reset | Jan 10, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2018 | Jul 4, 2018 | |||
| Jul 4, 2018 | Jan 10, 2019 |