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Ultrasound machine was no longer approved for use by Health Canada therefore study was closed prior to patients being enrolled on study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simple Bone Cyst Patients | Active Comparator | 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 | Active Comparator | 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 | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunlight Omnisense Quantitative Ultrasound | Device | Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Z-scores obtained using quantitative ultrasound | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Bone specific alkaline phosphatase | 2 years |
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Arm 1 - Simple Bone Cyst Patients
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Arm 2 - Healthy Controls
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Arm 3 - Fracture patients
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Howard, MD | The Hospital for Sick Children | Principal Investigator |
| James G. Wright, MD | Nuffield Orthopaedic Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| ID | Term |
|---|---|
| D001845 | Bone Cysts |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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