Simple Bone Cysts in Kids (SBoCK)
Primary Purpose
Bone Cyst
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Curettage with puncture (C & P)
Curette
Vitoss morsels
Sponsored by
About this trial
This is an interventional treatment trial for Bone Cyst focused on measuring Simple bone cyst, Unicameral bone cyst
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with bone disease (ie. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
- Pregnant or breastfeeding female
- Patients with cysts crossing the growth plate (area where bone grows)
Sites / Locations
- Children's Hospital of Alabama
- Loma Linda UniversityRecruiting
- Nemours/Alfred I. duPont Hospital for Children
- Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
- The John Hopkins Hospital
- The Children's Hospital at Montefiore
- Hospital for Joint Diseases
- Hospital for Special Surgery
- University of North Carolina - Chapel HillRecruiting
- Cincinnati Children's Hospital Medical Center
- Texas Children's HospitalRecruiting
- The Royal Children's HospitalRecruiting
- Alberta Children's HospitalRecruiting
- BC Children's HospitalRecruiting
- Winnipeg Health Sciences Centre
- IWK Health CentreRecruiting
- Children's Hospital at London Health Sciences CentreRecruiting
- Children's Hospital of Eastern OntarioRecruiting
- The Hospital for Sick ChildrenRecruiting
- Shriners Hospital for Children - Canadian Unit
- Alder Hey Children's HospitalRecruiting
- Great Ormond Street Hospital for ChildrenRecruiting
- Royal Manchester Children's HospitalRecruiting
- Nuffield Orthopaedic CentreRecruiting
- Sheffield Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
C & P
C & P with Vitoss
Arm Description
Curettage with puncture (C & P) will be performed alone
A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C & P)
Outcomes
Primary Outcome Measures
Cyst healing
Healing will be graded according to a 4-point modified Neer's classification by radiologists
Secondary Outcome Measures
Clinical measures (Cyst features)
Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
Functional measures (Questionnaire scores)
Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment
Full Information
NCT ID
NCT02193841
First Posted
July 4, 2014
Last Updated
July 10, 2023
Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT02193841
Brief Title
Simple Bone Cysts in Kids
Acronym
SBoCK
Official Title
Simple Bone Cysts in Kids (SBoCK)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
In general, few randomized clinical trials have been undertaken in paediatric orthopaedics, and only one to date has addressed the problem of simple bone cysts (SBCs). Also known as unicameral bone cysts, they are the commonest bone lesion in children. Despite general opinion, these cysts do not resolve at skeletal maturity.
Many forms of treatment have been recommended but none, including the popular methods of corticosteroid or bone marrow injections, have reliably eradicated SBC. Although the lesions are considered benign (non-cancerous), they cause pain, frequently interfere with function, dramatically restrict play activity, may re-fracture leading to growth arrest and/or deformity, and cause enormous anxiety for children and their families.
With a well-developed network of surgeons and researchers, we will provide evidence comparing the effectiveness of two treatment interventions for SBC. More specifically, our goals for this study are:
to compare the rate of radiographic healing between two standard treatments including curettage with puncture alone, and curettage with puncture followed by injection with Vitoss morsels;
to identify prognostic radiographic factors associated with simple bone cyst healing and fracture;
to determine the impact of simple bone cyst on children/family functioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Cyst
Keywords
Simple bone cyst, Unicameral bone cyst
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C & P
Arm Type
Active Comparator
Arm Description
Curettage with puncture (C & P) will be performed alone
Arm Title
C & P with Vitoss
Arm Type
Active Comparator
Arm Description
A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C & P)
Intervention Type
Procedure
Intervention Name(s)
Curettage with puncture (C & P)
Intervention Description
A curette will be inserted to scrape the contents of the cyst (curettage) and a hole in the cyst wall will be made (puncture) near the bone marrow cavity
Intervention Type
Device
Intervention Name(s)
Curette
Intervention Description
A small surgical instrument with a rounded edge designed for scraping
Intervention Type
Device
Intervention Name(s)
Vitoss morsels
Other Intervention Name(s)
Tri-calcium phosphate bone graft substitute
Intervention Description
A bone substitute intended for use as a filler for voids or gaps in bones
Primary Outcome Measure Information:
Title
Cyst healing
Description
Healing will be graded according to a 4-point modified Neer's classification by radiologists
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Clinical measures (Cyst features)
Description
Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
Time Frame
1 and 2 years
Title
Functional measures (Questionnaire scores)
Description
Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment
Time Frame
1 and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients with bone disease (ie. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
Pregnant or breastfeeding female
Patients with cysts crossing the growth plate (area where bone grows)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Project Manager
Email
sbock.study@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James G. Wright
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sevan Hopyan
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Withdrawn
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Clarke
Email
EAClarke@llu.edu
First Name & Middle Initial & Last Name & Degree
Martin Morrison III
Facility Name
Nemours/Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Completed
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carly Strohbach
Email
cstrohbach@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Jamie Burgess
Email
jburgess@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Joseph A Janicki
Facility Name
The John Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Completed
Facility Name
Hospital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Withdrawn
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Titter
Email
julie_titter@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Anna Vergun
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Completed
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Anand
Email
gxanand@texaschildrens.org
First Name & Middle Initial & Last Name & Degree
Vinitha R Shenava
Facility Name
The Royal Children's Hospital
City
Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Formosa
Email
melissa.formosa@mcri.edu.au
First Name & Middle Initial & Last Name & Degree
Brian Loh
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoga Dhanapala
Email
yndhanap@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Elaine Joughin
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harpreet Chhina
Email
HChhina@cw.bc.ca
Email
HChhina@cw.bc.ca
First Name & Middle Initial & Last Name & Degree
Tony Cooper
First Name & Middle Initial & Last Name & Degree
Kishore Mulpuri
Facility Name
Winnipeg Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Individual Site Status
Withdrawn
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Hurry
Email
Jennifer.Hurry@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Karl Logan
Facility Name
Children's Hospital at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Davidson
Email
Jacob.Davidson@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Debra Bartley
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Livock
Email
HLivock@cheo.on.ca
First Name & Middle Initial & Last Name & Degree
Sasha Carsen
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Shiu
Email
julie.shiu@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Sevan Hopyan
Facility Name
Shriners Hospital for Children - Canadian Unit
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A6
Country
Canada
Individual Site Status
Completed
Facility Name
Alder Hey Children's Hospital
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Spink
Email
emma.spink@alderhey.nhs.uk
First Name & Middle Initial & Last Name & Degree
Dan Perry
Facility Name
Great Ormond Street Hospital for Children
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Gardiner
Email
kim.gardiner@gosh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Andreas Roposch
Facility Name
Royal Manchester Children's Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imelda Mayor
Email
imelda.mayor@mft.nhs.uk
First Name & Middle Initial & Last Name & Degree
Mohamed Kenawey
Facility Name
Nuffield Orthopaedic Centre
City
Oxford
ZIP/Postal Code
OX3 7HE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Harmer
Email
rebecca.harmer@ouh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Tim Theologis
Facility Name
Sheffield Children's Hospital
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee Corcoran
Email
aimee.corcoran@nhs.net
First Name & Middle Initial & Last Name & Degree
Nicolas Nicolaou
12. IPD Sharing Statement
Citations:
PubMed Identifier
18381307
Citation
Wright JG, Yandow S, Donaldson S, Marley L; Simple Bone Cyst Trial Group. A randomized clinical trial comparing intralesional bone marrow and steroid injections for simple bone cysts. J Bone Joint Surg Am. 2008 Apr;90(4):722-30. doi: 10.2106/JBJS.G.00620.
Results Reference
background
PubMed Identifier
21191299
Citation
Donaldson S, Wright JG. Recent developments in treatment for simple bone cysts. Curr Opin Pediatr. 2011 Feb;23(1):73-7. doi: 10.1097/MOP.0b013e3283421111.
Results Reference
background
PubMed Identifier
21150732
Citation
Canavese F, Wright JG, Cole WG, Hopyan S. Unicameral bone cysts: comparison of percutaneous curettage, steroid, and autologous bone marrow injections. J Pediatr Orthop. 2011 Jan-Feb;31(1):50-5. doi: 10.1097/BPO.0b013e3181ff7510.
Results Reference
background
PubMed Identifier
21808696
Citation
Donaldson S, Chundamala J, Yandow S, Wright JG. Treatment for unicameral bone cysts in long bones: an evidence based review. Orthop Rev (Pavia). 2010 Mar 20;2(1):e13. doi: 10.4081/or.2010.e13.
Results Reference
background
Links:
URL
http://www.sickkids.ca/research/sbock/
Description
SBoCK Trial Website
Learn more about this trial
Simple Bone Cysts in Kids
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