Simple Bone Cysts in Kids

Last updated: July 10, 2023
Sponsor: The Hospital for Sick Children
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Vitoss morsels

Curette

Curettage with puncture (C & P)

Clinical Study ID

NCT02193841
1000042364
  • Ages 2-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 informedconsent (and assent, when appropriate)
  • Patients with stabilizing implants in the bone where the cyst is located

Exclusion

Exclusion Criteria:

  • Patients with bone disease (ie. osteogenesis imperfecta, cancer, osteoporosis, Paget'sdisease)
  • Pregnant or breastfeeding female
  • Patients with cysts crossing the growth plate (area where bone grows)

Study Design

Total Participants: 160
Treatment Group(s): 3
Primary Treatment: Vitoss morsels
Phase: 3
Study Start date:
March 01, 2015
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • The Royal Children's Hospital

    Melbourne,
    Australia

    Active - Recruiting

  • Alberta Children's Hospital

    Calgary, Alberta T3B 6A8
    Canada

    Active - Recruiting

  • BC Children's Hospital

    Vancouver, British Columbia V6H 3V4
    Canada

    Active - Recruiting

  • Winnipeg Health Sciences Centre

    Winnipeg, Manitoba R3A 1R9
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Active - Recruiting

  • Children's Hospital at London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8L1
    Canada

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Shriners Hospital for Children - Canadian Unit

    Montreal, Quebec H3G 1A6
    Canada

    Completed

  • Sidra Medical and Research Center

    Doha,
    Qatar

    Site Not Available

  • Royal Hospital for Children

    Glasgow,
    United Kingdom

    Site Not Available

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital for Children

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • The Robert Jones and Agnes Hunt Orthopaedic Hospital

    Oswestry, SY10 7AG
    United Kingdom

    Site Not Available

  • Nuffield Orthopaedic Centre

    Oxford, OX3 7HE
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital

    Western Bank Sheffield, S10 2TH
    United Kingdom

    Site Not Available

  • Children's Hospital of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Active - Recruiting

  • Good Samaritan Hospital

    San Jose, California 95124
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Nemours/Alfred I. duPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Completed

  • Nemours Children's Clinic-Pensacola

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Shriners Hospital for Children

    Honolulu, Hawaii 96826
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • The John Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • The Children's Hospital at Montefiore

    Bronx, New York 10467
    United States

    Completed

  • Hospital for Joint Diseases

    New York, New York 10003
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Completed

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

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