Simple Bone Cysts in Kids (SBoCK)

July 10, 2023 updated by: James Wright, The Hospital for Sick Children

Simple Bone Cysts in Kids (SBoCK)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Melbourne, Australia
        • Recruiting
        • The Royal Children's Hospital
        • Contact:
        • Principal Investigator:
          • Brian Loh
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital
        • Contact:
        • Principal Investigator:
          • Elaine Joughin
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Recruiting
        • BC Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tony Cooper
        • Principal Investigator:
          • Kishore Mulpuri
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Withdrawn
        • Winnipeg Health Sciences Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Children's Hospital at London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Debra Bartley
      • Ottawa, Ontario, Canada, K1H 8L1
        • Recruiting
        • Children's Hospital of Eastern Ontario
        • Contact:
        • Principal Investigator:
          • Sasha Carsen
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Sevan Hopyan
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A6
        • Completed
        • Shriners Hospital for Children - Canadian Unit
  • United Kingdom
      • Liverpool, United Kingdom, L12 2AP
        • Recruiting
        • Alder Hey Children's Hospital
        • Contact:
        • Principal Investigator:
          • Dan Perry
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children
        • Contact:
        • Principal Investigator:
          • Andreas Roposch
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Royal Manchester Children's Hospital
        • Contact:
        • Principal Investigator:
          • Mohamed Kenawey
      • Oxford, United Kingdom, OX3 7HE
        • Recruiting
        • Nuffield Orthopaedic Centre
        • Contact:
        • Principal Investigator:
          • Tim Theologis
      • Sheffield, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children's Hospital
        • Contact:
        • Principal Investigator:
          • Nicolas Nicolaou
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Withdrawn
        • Children's Hospital of Alabama
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University
        • Principal Investigator:
          • Martin Morrison III
        • Contact:
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Completed
        • Nemours/Alfred I. duPont Hospital for Children
    • Illinois
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Withdrawn
        • The John Hopkins Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Completed
        • The Children's Hospital at Montefiore
      • New York, New York, United States, 10003
        • Withdrawn
        • Hospital for Joint Diseases
      • New York, New York, United States, 10021
        • Withdrawn
        • Hospital For Special Surgery
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina - Chapel Hill
        • Contact:
        • Principal Investigator:
          • Anna Vergun
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Completed
        • Cincinnati Children's Hospital Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
        • Principal Investigator:
          • Vinitha R Shenava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: C & P
Curettage with puncture (C & P) will be performed alone
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
Active Comparator: C & P with Vitoss
A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C & P)
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
Device: Vitoss morsels
A bone substitute intended for use as a filler for voids or gaps in bones
Other Names:
  • Tri-calcium phosphate bone graft substitute

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cyst healing
Time Frame: 2 years
Healing will be graded according to a 4-point modified Neer's classification by radiologists
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical measures (Cyst features)
Time Frame: 1 and 2 years
Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
1 and 2 years
Functional measures (Questionnaire scores)
Time Frame: 1 and 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: James G. Wright, The Hospital for Sick Children
  • Principal Investigator: Sevan Hopyan, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimated)

July 18, 2014

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000042364

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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