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NCT02193841PHASE3Recruiting

Simple Bone Cysts in Kids

The Hospital for Sick Children

Start Date

3/1/2015

Completion Date

3/1/2027

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

Age Range: 2 years to 21 years

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)

Interventions

PROCEDURE

Curettage with puncture (C & P)

DEVICE

Curette

DEVICE

Vitoss morsels

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Conditions

Bone Cyst

Locations

Children's Hospital of Alabama

Birmingham, Alabama 35233

United States

Loma Linda University

Loma Linda, California 92354

United States

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware 19803

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

The John Hopkins Hospital

Baltimore, Maryland 21287

United States

Hospital for Joint Diseases

New York, New York 10003

United States

Hospital for Special Surgery

New York, New York 10021

United States

The Children's Hospital at Montefiore

The Bronx, New York 10467

United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina 27599

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Texas Children's Hospital

Houston, Texas 77030

United States

The Royal Children's Hospital

Melbourne,

Australia

Alberta Children's Hospital

Calgary, Alberta T3B 6A8

Canada

BC Children's Hospital

Vancouver, British Columbia V6H 3V4

Canada

Winnipeg Health Sciences Centre

Winnipeg, Manitoba R3A 1R9

Canada

IWK Health Centre

Halifax, Nova Scotia B3K 6R8

Canada

Children's Hospital at London Health Sciences Centre

London, Ontario N6A 5W9

Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario K1H 8L1

Canada

The Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada

Shriners Hospital for Children - Canadian Unit

Montreal, Quebec H3G 1A6

Canada

Alder Hey Children's Hospital

Liverpool, L12 2AP

United Kingdom

Great Ormond Street Hospital for Children

London, WC1N 3JH

United Kingdom

Royal Manchester Children's Hospital

Manchester, M13 9WL

United Kingdom

Nuffield Orthopaedic Centre

Oxford, OX3 7HE

United Kingdom

Sheffield Children's Hospital

Sheffield, S10 2TH

United Kingdom