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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
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
A small surgical instrument with a rounded edge designed for scraping
A bone substitute intended for use as a filler for voids or gaps in bones
Cyst healing
Healing will be graded according to a 4-point modified Neer's classification by radiologists
Time frame: 2 years
Clinical measures (Cyst features)
Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
Time frame: 1 and 2 years
Functional measures (Questionnaire scores)
Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment
Time frame: 1 and 2 years
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Children's Hospital of Alabama
Birmingham, Alabama, United States
WITHDRAWNLoma Linda University
Loma Linda, California, United States
RECRUITINGNemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
COMPLETEDAnn & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGThe John Hopkins Hospital
Baltimore, Maryland, United States
WITHDRAWNHospital for Joint Diseases
New York, New York, United States
WITHDRAWNHospital for Special Surgery
New York, New York, United States
WITHDRAWNThe Children's Hospital at Montefiore
The Bronx, New York, United States
COMPLETEDUniversity of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
COMPLETED...and 15 more locations