Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02616757

Enrollment

Registered

2015-11-30

Start date

2016-10-31

Completion date

2021-01-06

Last updated

2021-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simple Bone Cyst

Brief 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.

Interventions

DEVICESunlight Omnisense Quantitative Ultrasound

Ultrasound

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 21 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Z-scores obtained using quantitative ultrasound	2 years

Secondary

Measure	Time frame
Bone specific alkaline phosphatase	2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026