Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

Study Overview
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Brief Summary
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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.

Official Title
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Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

Conditions
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Simple Bone Cyst

Intervention / Treatment
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* Device: Sunlight Omnisense Quantitative Ultrasound


Participation Criteria
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Eligibility Criteria
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Arm 1 - Simple Bone Cyst Patients Inclusion Criteria Patients ≥ 2 and ≤ 21 years Patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration 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 Patients with implants to stabilize the bone where the cyst is located. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease) Patients who are pregnant or breastfeeding Patients with a simple bone cyst crossing the growth plate Arm 2 - Healthy Controls Inclusion Criteria Patients ≥ 2 and ≤ 21 years 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 Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease) Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.) Patients who are pregnant or breastfeeding Arm 3 - Fracture patients Inclusion Criteria Patients ≥ 2 and ≤ 21 years Patients who have undergone any type of casting or surgical treatment for their fracture 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 Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease) Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.) Patients who are pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simple Bone Cyst Patients<br>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<br>* Ultrasound<br>|
| Active Comparator: Fracture patients<br>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<br>* Ultrasound<br>|
| Placebo Comparator: Health volunteers<br>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<br>* Ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone specific alkaline phosphatase |  | 2 years |