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

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

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).

Study Overview

• Status: Completed
• Conditions: Clinical Trial; Comparative Effectiveness Research; Equipment Safety
• Intervention / Treatment: Device: Oste-scan 500A; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University
• Investigators: Principal Investigator: Huijie Zhang, Doctor, Office Director of Clinical Trial Institution

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): March 9, 2017
• Study Completion (Actual): March 9, 2017

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 19, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HJHC-YLQX2016001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No