Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

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.

Study Overview

• Status: Withdrawn
• Conditions: Simple Bone Cyst
• Intervention / Treatment: Device: Sunlight Omnisense Quantitative Ultrasound

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Arm 1 - Simple Bone Cyst Patients

Inclusion Criteria

1. Patients ≥ 2 and ≤ 21 years
2. Patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration
3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

1. Patients with implants to stabilize the bone where the cyst is located.
2. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
3. Patients who are pregnant or breastfeeding
4. Patients with a simple bone cyst crossing the growth plate

Arm 2 - Healthy Controls

Inclusion Criteria

1. Patients ≥ 2 and ≤ 21 years
2. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

1. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
3. Patients who are pregnant or breastfeeding

Arm 3 - Fracture patients

Inclusion Criteria

1. Patients ≥ 2 and ≤ 21 years
2. Patients who have undergone any type of casting or surgical treatment for their fracture
3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

1. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
3. Patients who are pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Simple Bone Cyst Patients; 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.	Device: Sunlight Omnisense Quantitative Ultrasound; Ultrasound
Active Comparator: Fracture patients; 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.	Device: Sunlight Omnisense Quantitative Ultrasound; Ultrasound
Placebo Comparator: Health volunteers; 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.	Device: Sunlight Omnisense Quantitative Ultrasound; Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Z-scores obtained using quantitative ultrasound	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Bone specific alkaline phosphatase	2 years

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Andrew Howard, MD, The Hospital for Sick Children; Principal Investigator: James G. Wright, MD, Nuffield Orthopaedic Centre

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): January 6, 2021
• Study Completion (Actual): January 6, 2021

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 30, 2015

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Cysts; Bone Cysts
• Other Study ID Numbers: 1000049774