Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

Not Applicable

Withdrawn

• Conditions: Simple Bone Cyst
• Interventions: Device: Sunlight Omnisense Quantitative Ultrasound

• Registration Number: NCT02616757
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

Simple bone cysts (SBCs), also known as unicameral bone cysts (UBCs), are benign bone lesions. Literature to date describes little agreement between clinicians on specific prognostic criteria for the prediction of cyst healing, recurrence or fracture. Evidence has shown that bone mineral density (BMD) is a reliable indicator of risk to SBC patients given its association with the mechanical properties of bone. There has been further exploration into the use of quantitative ultrasound to assess bone density by measuring the velocity of the ultrasound transmission over the bone. To determine whether the QUS can provide prognostic information with respect to cyst healing, recurrence or fracture with a SBC, further study is needed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-30
• Study Start: 2016-10
• Primary Completion: 2021-01-06
• Study Completion: 2021-01-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simple Bone Cyst Patients	Sunlight Omnisense Quantitative Ultrasound	Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline and once annually for 2 years. There will also be optional blood samples taken o measure bone alkaline phosphatase.
Fracture patients	Sunlight Omnisense Quantitative Ultrasound	Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline, after 3 months and at future follow-up visits as clinically indicated or at a one year follow-up visit. There will also be optional blood samples taken to measure bone alkaline phosphatase.
Health volunteers	Sunlight Omnisense Quantitative Ultrasound	Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline, after 3 months and at a one year follow-up visit. There will also be optional blood samples taken to measure bone alkaline phosphatase.

Primary Outcome Measures

Name	Time	Method
Z-scores obtained using quantitative ultrasound	2 years

Secondary Outcome Measures

Name	Time	Method
Bone specific alkaline phosphatase	2 years

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada