Recruiting

Phase 3

Observational StudySimple Bone Cysts in Kids

Sponsor:

The Hospital for Sick Children

Code:

NCT02193841

Conditions

Bone Cyst

Eligibility Criteria

Sex: All

Age: 2 - 21

Healthy Volunteers: Not accepted

Interventions

Curettage with puncture (C & P)

Curette

Vitoss morsels

Study Details

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.

Conditions

Bone Cyst

Study ID

NCT02193841

Start date

Mar, 2015

Status verified date

Jul, 2023

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: C & P

Curettage with puncture (C \& P) will be performed alone

active comparator: C & P with Vitoss

A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)

Interventions

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

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

Primary outcome measure

Cyst healing [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Project Manager

sbock.study@sickkids.ca

Locations

Loma Linda University

Recruiting

Loma Linda, California, United States, 92354

Contacts

Elisabeth Clarke

EAClarke@llu.edu

Principal Investigator:

Martin Morrison III

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Carly Strohbach

cstrohbach@luriechildrens.org

Jamie Burgess

jburgess@luriechildrens.org

Principal Investigator:

Joseph A Janicki

University of North Carolina - Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Julie Titter

julie_titter@med.unc.edu

Principal Investigator:

Anna Vergun

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Grace Anand

gxanand@texaschildrens.org

Principal Investigator:

Vinitha R Shenava

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Yoga Dhanapala

yndhanap@ucalgary.ca

Principal Investigator:

Elaine Joughin

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

Harpreet Chhina

HChhina@cw.bc.ca

Principal Investigator:

Tony Cooper

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Jennifer Hurry

Jennifer.Hurry@iwk.nshealth.ca

Principal Investigator:

Karl Logan

Children's Hospital at London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Jacob Davidson

Jacob.Davidson@lhsc.on.ca

Principal Investigator:

Debra Bartley

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Holly Livock

HLivock@cheo.on.ca

Principal Investigator:

Sasha Carsen

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Julie Shiu

julie.shiu@sickkids.ca

Principal Investigator:

Sevan Hopyan

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Jul 12, 2023

Last verified

Jul, 2023

Keywords

Simple bone cyst
Unicameral bone cyst

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2023-07-12.