NCT02193841

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
10mo left

Started Mar 2015

Longer than P75 for phase_3

Geographic Reach
4 countries

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Mar 2015Mar 2027

First Submitted

Initial submission to the registry

July 4, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

12 years

First QC Date

July 4, 2014

Last Update Submit

July 10, 2023

Conditions

Bone Cyst

Keywords

Simple bone cystUnicameral bone cyst

Outcome Measures

Primary Outcomes (1)

  • Cyst healing

    Healing will be graded according to a 4-point modified Neer's classification by radiologists

    2 years

Secondary Outcomes (2)

  • Clinical measures (Cyst features)

    1 and 2 years

  • Functional measures (Questionnaire scores)

    1 and 2 years

Study Arms (2)

C & P

ACTIVE COMPARATOR

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

Procedure: Curettage with puncture (C & P)Device: Curette

C & P with Vitoss

ACTIVE COMPARATOR

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

Procedure: Curettage with puncture (C & P)Device: CuretteDevice: Vitoss morsels

Interventions

Curettage with puncture (C & P)PROCEDURE

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

C & PC & P with Vitoss
CuretteDEVICE

A small surgical instrument with a rounded edge designed for scraping

C & PC & P with Vitoss
Vitoss morselsDEVICE

A bone substitute intended for use as a filler for voids or gaps in bones

Also known as: Tri-calcium phosphate bone graft substitute
C & P with Vitoss

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

WITHDRAWN

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

COMPLETED

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

Chicago, Illinois, 60611, United States

RECRUITING

The John Hopkins Hospital

Baltimore, Maryland, 21287, United States

WITHDRAWN

Hospital for Joint Diseases

New York, New York, 10003, United States

WITHDRAWN

Hospital for Special Surgery

New York, New York, 10021, United States

WITHDRAWN

The Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

COMPLETED

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

COMPLETED

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

The Royal Children's Hospital

Melbourne, Australia

RECRUITING

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

WITHDRAWN

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Children's Hospital at London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Shriners Hospital for Children - Canadian Unit

Montreal, Quebec, H3G 1A6, Canada

COMPLETED

Alder Hey Children's Hospital

Liverpool, L12 2AP, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

RECRUITING

Royal Manchester Children's Hospital

Manchester, M13 9WL, United Kingdom

RECRUITING

Nuffield Orthopaedic Centre

Oxford, OX3 7HE, United Kingdom

RECRUITING

Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18381307BACKGROUND

  • 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.

    PMID: 21191299BACKGROUND

  • 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.

    PMID: 21150732BACKGROUND

  • 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.

    PMID: 21808696BACKGROUND

Related Links

MeSH Terms

Conditions

Bone Cysts

Interventions

CurettagePunctures

Condition Hierarchy (Ancestors)

CystsNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeTherapeutics

Study Officials

  • James G. Wright

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

  • Sevan Hopyan

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

sbock.study@sickkids.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 18, 2014

Study Start

March 1, 2015

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations

AU(1)US(11)CA(8)GB(5)