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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02193841
Registration number
NCT02193841
Ethics application status
Date submitted
4/07/2014
Date registered
18/07/2014
Date last updated
12/07/2023
Titles & IDs
Public title
Simple Bone Cysts in Kids
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Scientific title
Simple Bone Cysts in Kids (SBoCK)
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Secondary ID [1]
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1000042364
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Universal Trial Number (UTN)
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Trial acronym
SBoCK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bone Cyst
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Curettage with puncture (C & P)
Treatment: Devices - Curette
Treatment: Devices - Vitoss morsels
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)
Treatment: Surgery: Curettage with puncture (C & P)
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
Treatment: Devices: Curette
A small surgical instrument with a rounded edge designed for scraping
Treatment: Devices: Vitoss morsels
A bone substitute intended for use as a filler for voids or gaps in bones
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cyst healing
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Assessment method [1]
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Healing will be graded according to a 4-point modified Neer's classification by radiologists
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Clinical measures (Cyst features)
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Assessment method [1]
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Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
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Timepoint [1]
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1 and 2 years
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Secondary outcome [2]
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Functional measures (Questionnaire scores)
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Assessment method [2]
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Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment
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Timepoint [2]
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1 and 2 years
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Eligibility
Key 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
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Minimum age
2
Years
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2027
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Actual
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Sample size
Target
160
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Royal Children's Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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California
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United States of America
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Delaware
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Texas
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Canada
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Alberta
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Canada
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British Columbia
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Country [12]
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Canada
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Manitoba
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Country [13]
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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United Kingdom
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Liverpool
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United Kingdom
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London
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Country [18]
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United Kingdom
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Manchester
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United Kingdom
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Oxford
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Country [20]
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United Kingdom
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State/province [20]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Hospital for Sick Children
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02193841
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Trial related presentations / publications
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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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James G. Wright
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Address
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The Hospital for Sick Children
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Phone
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Fax
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Email
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Contact person for public queries
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Project Manager
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Address
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Phone
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02193841
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