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Brief Title: Simple Bone Cysts in Kids
Official Title: Simple Bone Cysts in Kids (SBoCK)
Study ID: NCT02193841
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: 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.
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
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
The Children's Hospital at Montefiore, Bronx, New York, United States
Hospital for Joint Diseases, New York, New York, United States
Hospital for Special Surgery, New York, 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
Name: James G. Wright
Affiliation: The Hospital for Sick Children
Role: PRINCIPAL_INVESTIGATOR
Name: Sevan Hopyan
Affiliation: The Hospital for Sick Children
Role: PRINCIPAL_INVESTIGATOR