Simple Bone Cysts in Kids (SBoCK)
Who is this study for? Patients with Bone Cyst
What treatments are being studied? Vitoss Morsels
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of two common treatments that are used by surgeons today.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 21
Healthy Volunteers: No
View:
• Patients with a confirmed simple bone cyst in a long bone (ie. arm or leg) within last 3 months
• At least 3 weeks must have elapsed since last fracture
• At least 3 months must have elapsed since last cyst treatment
• Patients and/or their legal representatives willing to provide written informed consent (and assent, when appropriate)
• Patients with stabilizing implants in the bone where the cyst is located
Locations
United States
Alabama
Children's Hospital of Alabama
Recruiting
Birmingham
California
Loma Linda University
Recruiting
Loma Linda
Delaware
Nemours/Alfred I. duPont Hospital for Children
Completed
Wilmington
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Recruiting
Chicago
Maryland
The John Hopkins Hospital
Recruiting
Baltimore
North Carolina
University of North Carolina - Chapel Hill
Recruiting
Chapel Hill
New York
The Children's Hospital at Montefiore
Recruiting
Bronx
Hospital for Joint Diseases
Withdrawn
New York
Hospital for Special Surgery
Withdrawn
New York
Ohio
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Texas
Texas Children's Hospital
Recruiting
Houston
Other Locations
Australia
The Royal Children's Hospital
Recruiting
Melbourne
Canada
Alberta Children's Hospital
Recruiting
Calgary
IWK Health Centre
Recruiting
Halifax
Children's Hospital at London Health Sciences Centre
Recruiting
London
Shriners Hospital for Children - Canadian Unit
Completed
Montreal
Children's Hospital of Eastern Ontario
Recruiting
Ottawa
The Hospital for Sick Children
Recruiting
Toronto
BC Children's Hospital
Recruiting
Vancouver
Winnipeg Health Sciences Centre
Withdrawn
Winnipeg
United Kingdom
Alder Hey Children's Hospital
Recruiting
Liverpool
Great Ormond Street Hospital for Children
Recruiting
London
Royal Manchester Children's Hospital
Recruiting
Manchester
Nuffield Orthopaedic Centre
Recruiting
Oxford
Sheffield Children's Hospital
Recruiting
Sheffield
Contact Information
Primary
Julie Shiu
julie.shiu@sickkids.ca
Time Frame
Start Date: March 2015
Estimated Completion Date: March 2024
Participants
Target number of participants: 160
Treatments
Active Comparator: C & P
Curettage with puncture (C & P) will be performed alone
Active Comparator: C & P with Vitoss
A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C & P)
Authors
Dan Perry, Tony Cooper, Anna Vergun, Emily Dodwell, Shawn R Gilbert, Jacob F Schulz, Vinitha R Shenava, Martin Morrison III, James G. Wright, Mihir Thacker, Jenny Frances, Sasha Carsen, Jason Howard, David Godfried, Joseph A Janicki, Joel Sorger, Alice Chu, Jay Lee, Anna V Cuomo, Sattar Alshryda, Andrew Wainwright, Andreas Roposch, Nicolas Nicolaou, Mohamed Kenawey, Roderick Duncan, Ibrar Majid, Paul Jellicoe, Megan S Cashin, Karl Logan, Brian Loh, Tim Theologis, Talal Ibrahim, Kishore Mulpuri, Jeff S Kanel, Elaine Joughin, Reggie C Hamdy, Sevan Hopyan
Sponsors
Leads: The Hospital for Sick Children
Collaborators: Canadian Institutes of Health Research (CIHR)