Clinical trial NCT02193841: Simple Bone Cysts in Kids
Official title: Simple Bone Cysts in Kids (SBoCK)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bone Cyst
Keywords: Simple bone cyst
Unicameral bone cyst
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-07-18
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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)

Primary outcomes:
measure: Cyst healing
timeFrame: 2 years
Secondary outcomes:
measure: Clinical measures (Cyst features)
timeFrame: 1 and 2 years
measure: Functional measures (Questionnaire scores)
timeFrame: 1 and 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Wilmington
country: United States
facility: Nemours/Alfred I. duPont Hospital for Children
state: Delaware
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Baltimore
country: United States
facility: The John Hopkins Hospital
state: Maryland
city: Bronx
country: United States
facility: The Children's Hospital at Montefiore
state: New York
city: New York
country: United States
facility: Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Melbourne
country: Australia
facility: The Royal Children's Hospital
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Centre
state: Manitoba
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: London
country: Canada
facility: Children's Hospital at London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Shriners Hospital for Children - Canadian Unit
state: Quebec
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
affiliation: The Hospital for Sick Children
name: James G. Wright
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Sevan Hopyan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.