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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02616757
Other study ID # 1000049774
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03724630 - The Results of Multiple Aspirations and Injections of Unicameral Bone Cyst by Methyl Prednisolone Acetate