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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 July 2023 |
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Main ID: |
NCT02193841 |
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Date of registration:
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04/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Simple Bone Cysts in Kids
SBoCK |
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Scientific title:
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Simple Bone Cysts in Kids (SBoCK) |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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160 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02193841 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Canada
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Qatar
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United Kingdom
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United States
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Contacts
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Name:
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Sevan Hopyan |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children |
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Name:
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Project Manager |
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Address:
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Telephone:
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Email:
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sbock.study@sickkids.ca |
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Affiliation:
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Name:
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James G. Wright |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children |
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Key inclusion & exclusion criteria
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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)
Age minimum:
2 Years
Age maximum:
21 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bone Cyst
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Intervention(s)
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Device: Curette
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Device: Vitoss morsels
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Procedure: Curettage with puncture (C & P)
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Primary Outcome(s)
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Cyst healing
[Time Frame: 2 years]
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Secondary Outcome(s)
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Functional measures (Questionnaire scores)
[Time Frame: 1 and 2 years]
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Clinical measures (Cyst features)
[Time Frame: 1 and 2 years]
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Secondary ID(s)
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1000042364
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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