Simple Bone Cysts in Kids (SBoCK)
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.
Arms & interventions
- ProcedureCurettage 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
- DeviceCurette
A small surgical instrument with a rounded edge designed for scraping
- DeviceVitoss morsels
A bone substitute intended for use as a filler for voids or gaps in bones
Outcome measures
Primary
Cyst healing
Healing will be graded according to a 4-point modified Neer's classification by radiologists
Time frame: 2 years
Secondary
Clinical measures (Cyst features)
Time frame: 1 and 2 years
Functional measures (Questionnaire scores)
Time frame: 1 and 2 years
Eligibility criteria
Study locations (11)
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Loma Linda University
Loma Linda, California, 92354
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
The John Hopkins Hospital
Baltimore, Maryland, 21287
Hospital for Joint Diseases
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
The Children's Hospital at Montefiore
The Bronx, New York, 10467
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Texas Children's Hospital
Houston, Texas, 77030
References
- 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.(PubMed)
- 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.(PubMed)
- 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.(PubMed)
- 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.(PubMed)