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Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02616757
Collaborator
(none)
0
Enrollment
1
Location
3
Arms
51.2
Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Sunlight Omnisense Quantitative Ultrasound
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing
Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Jan 6, 2021
Actual Study Completion Date :
Jan 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Device: Sunlight Omnisense Quantitative Ultrasound
Ultrasound
Active Comparator: 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.

Device: Sunlight Omnisense Quantitative Ultrasound
Ultrasound
Placebo Comparator: 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.

Device: Sunlight Omnisense Quantitative Ultrasound
Ultrasound

Outcome Measures

Primary Outcome Measures

  1. Z-scores obtained using quantitative ultrasound [2 years]

Secondary Outcome Measures

  1. Bone specific alkaline phosphatase [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • The Hospital for Sick Children

Investigators

  • Principal Investigator: Andrew Howard, MD, The Hospital for Sick Children
  • Principal Investigator: James G. Wright, MD, Nuffield Orthopaedic Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James Wright, Orthopaedic Surgeon, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT02616757
Other Study ID Numbers:
  • 1000049774
First Posted:
Nov 30, 2015
Last Update Posted:
Apr 21, 2021
Last Verified:
Apr 1, 2021
Additional relevant MeSH terms:
Cysts
Bone Cysts

Study Results

No Results Posted as of Apr 21, 2021