Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

NCT ID: NCT02616757

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2021-01-06

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.

Conditions

Simple Bone Cyst

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Simple Bone Cyst Patients

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.

Group Type: ACTIVE_COMPARATOR

Sunlight Omnisense Quantitative Ultrasound

Intervention Type: DEVICE

Ultrasound

Fracture patients

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.

Group Type: ACTIVE_COMPARATOR

Sunlight Omnisense Quantitative Ultrasound

Intervention Type: DEVICE

Ultrasound

Health volunteers

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.

Group Type: PLACEBO_COMPARATOR

Sunlight Omnisense Quantitative Ultrasound

Intervention Type: DEVICE

Ultrasound

Interventions

Sunlight Omnisense Quantitative Ultrasound

Ultrasound

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

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 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

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

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

James Wright

Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Howard, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

James G. Wright, MD

Role: PRINCIPAL_INVESTIGATOR

Nuffield Orthopaedic Centre

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000049774

Identifier Type: -

Identifier Source: org_study_id