Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects

The Second Hospital of Nanjing Medical University150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

150

Conditions

Clinical Trial Comparative Effectiveness Research Equipment Safety

Interventions

Oste-scan 500ADEVICE

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).

SONOST3000DEVICE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject who need to measure calcaneal bone strength index. * Subject is a male or female subject 20-80 years of age. * Subject is willing and able to provide signed and dated written informed consent form. * Subject whose compliance is good and can cooperate to complete the clinical trial. Exclusion Criteria: * Subject whose heel skin fester or defect. * Subject has a history of allergic reactions to ultrasonic coupling agent. * Subject who is not cooperative obviously or nervous extremely. * Pregnant or lactating females. * Subject has a mental disease, without self-control. * Subject has participated in other clinical trial within a month.

Locations (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: 0-24 hours after detection

Secondary Outcomes

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.

Time frame: After detection

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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