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Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

Primary Purpose

Simple Bone Cyst

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sunlight Omnisense Quantitative Ultrasound
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Simple Bone Cyst

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Simple Bone Cyst Patients

Fracture patients

Health volunteers

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Z-scores obtained using quantitative ultrasound

Secondary Outcome Measures

Bone specific alkaline phosphatase

Full Information

First Posted
November 25, 2015
Last Updated
April 20, 2021
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT02616757
Brief Title
Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing
Official Title
Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Ultrasound machine was no longer approved for use by Health Canada therefore study was closed prior to patients being enrolled on study.
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 6, 2021 (Actual)
Study Completion Date
January 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Simple Bone Cyst

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simple Bone Cyst Patients
Arm Type
Active Comparator
Arm 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.
Arm Title
Fracture patients
Arm Type
Active Comparator
Arm 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.
Arm Title
Health volunteers
Arm Type
Placebo Comparator
Arm 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 a one year follow-up visit. There will also be optional blood samples taken to measure bone alkaline phosphatase.
Intervention Type
Device
Intervention Name(s)
Sunlight Omnisense Quantitative Ultrasound
Intervention Description
Ultrasound
Primary Outcome Measure Information:
Title
Z-scores obtained using quantitative ultrasound
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Bone specific alkaline phosphatase
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Howard, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James G. Wright, MD
Organizational Affiliation
Nuffield Orthopaedic Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

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