Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

Simple Bone Cyst Clinical Trial

Official title:

Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02616757
• Other study ID #: 1000049774
• Status: Withdrawn
• Phase: N/A
• Start date: October 2016
• Est. completion date: January 6, 2021

Study information

• Verified date: April 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Cysts
• Cysts
• Simple Bone Cyst

Intervention

Device:
• Sunlight Omnisense Quantitative Ultrasound
Ultrasound

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Z-scores obtained using quantitative ultrasound		2 years
Secondary	Bone specific alkaline phosphatase		2 years