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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Simple Bone Cysts in Kids (SBoCK)
Secondary ID [1] 0 0
1000042364
Universal Trial Number (UTN)
Trial acronym
SBoCK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Cyst 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cyst healing
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Clinical measures (Cyst features)
Timepoint [1] 0 0
1 and 2 years
Secondary outcome [2] 0 0
Functional measures (Questionnaire scores)
Timepoint [2] 0 0
1 and 2 years

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
Minimum age
2 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Manitoba
Country [13] 0 0
Canada
State/province [13] 0 0
Nova Scotia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Liverpool
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Manchester
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Oxford
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
The Hospital for Sick Children
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02193841
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.
Public notes

Contacts
Principal investigator
Name 0 0
James G. Wright
Address 0 0
The Hospital for Sick Children
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Project Manager
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02193841