Clinical trial · Interventional
Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Ultrasound machine was no longer approved for use by Health Canada therefore study was closed prior to patients being enrolled on study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Simple Bone Cyst | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunlight Omnisense Quantitative Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Simple Bone Cyst Patients
- description
- 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.
- interventionNames
- Device: Sunlight Omnisense Quantitative Ultrasound
- type
- ACTIVE_COMPARATOR
- label
- Fracture patients
- description
- 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.
- interventionNames
- Device: Sunlight Omnisense Quantitative Ultrasound
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available