Simple Bone Cysts in Kids

Bone Cyst Clinical Trial

— SBoCK  

Official title:

Simple Bone Cysts in Kids (SBoCK)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02193841
• Other study ID #: 1000042364
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: March 2027

Study information

• Verified date: July 2023
• Source: The Hospital for Sick Children
• Contact: Project Manager
• Email: sbock.study[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bone Cyst
• Bone Cysts
• Cysts

Intervention

Procedure:
• 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

Device:
• 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

Locations

Country	Name	City	State
Australia	The Royal Children's Hospital	Melbourne
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Children's Hospital at London Health Sciences Centre	London	Ontario
Canada	Shriners Hospital for Children - Canadian Unit	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia
Canada	Winnipeg Health Sciences Centre	Winnipeg	Manitoba
United Kingdom	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 States	The John Hopkins Hospital	Baltimore	Maryland
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	The Children's Hospital at Montefiore	Bronx	New York
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Texas Children's Hospital	Houston	Texas
United States	Loma Linda University	Loma Linda	California
United States	Hospital for Joint Diseases	New York	New York
United States	Hospital for Special Surgery	New York	New York
United States	Nemours/Alfred I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cyst healing	Healing will be graded according to a 4-point modified Neer's classification by radiologists	2 years
Secondary	Clinical measures (Cyst features)	Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment	1 and 2 years
Secondary	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	1 and 2 years

External Links

•   SBoCK Trial Website