Clinical trial NCT02971527: Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects
Official title: A Multicenter, Open-Labeled, Self-Paired Study to Examine the Effectiveness and Safety of Ultrasound Bone Strength Device Used for Measuring Calcaneal Bone Strength Index of Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Trial
Comparative Effectiveness Research
Equipment Safety
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the consistent rate of bone mineral density diagnosis
timeFrame: 0-24 hours after detection
Secondary outcomes:
measure: the accuracy of speed of sound(SOS)
timeFrame: After detection
measure: the accuracy of broadband ultrasound attenuation(BUA), stiffness(SI), T-scores and Z-scores
timeFrame: After detection
measure: the using performance evaluation index of the device, including function, stability and convenience
timeFrame: during detection and 0-24 hours after detection
measure: vital signs, including respiration, heart rate, blood pressure and temperature
timeFrame: before detection, during detection and 0-24 hours after detection
measure: clinical symptoms
timeFrame: before detection, during detection and 0-24 hours after detection
measure: skin allergy caused by the device
timeFrame: before detection, during detection and 0-24 hours after detection
measure: the number of participants with adverse events
timeFrame: in the entire trial
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Office Director of Clinical Trial Institution
name: Huijie Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: