Study Results
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Basic Information
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RECRUITING
PHASE3
160 participants
INTERVENTIONAL
2015-03-31
2027-03-31
Brief Summary
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Detailed Description
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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:
1. 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;
2. to identify prognostic radiographic factors associated with simple bone cyst healing and fracture;
3. to determine the impact of simple bone cyst on children/family functioning.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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C & P
Curettage with puncture (C \& P) will be performed alone
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
Curette
A small surgical instrument with a rounded edge designed for scraping
C & P with Vitoss
A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)
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
Curette
A small surgical instrument with a rounded edge designed for scraping
Vitoss morsels
A bone substitute intended for use as a filler for voids or gaps in bones
Interventions
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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
Curette
A small surgical instrument with a rounded edge designed for scraping
Vitoss morsels
A bone substitute intended for use as a filler for voids or gaps in bones
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or breastfeeding female
* Patients with cysts crossing the growth plate (area where bone grows)
2 Years
21 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
The Hospital for Sick Children
OTHER
Responsible Party
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James Wright
Orthopaedic Surgeon
Principal Investigators
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James G. Wright
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Sevan Hopyan
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
Loma Linda University
Loma Linda, California, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
The John Hopkins Hospital
Baltimore, Maryland, United States
Hospital for Joint Diseases
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
The Children's Hospital at Montefiore
The Bronx, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
The Royal Children's Hospital
Melbourne, , Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Children's Hospital at London Health Sciences Centre
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Shriners Hospital for Children - Canadian Unit
Montreal, Quebec, Canada
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
Nuffield Orthopaedic Centre
Oxford, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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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.
Related Links
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SBoCK Trial Website
Other Identifiers
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1000042364
Identifier Type: -
Identifier Source: org_study_id
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