Bone CystPhase 3SBoCKNCT02193841
Simple Bone Cysts in Kids
A Phase 3 study testing Curettage with puncture (C & P), Curette and Vitoss morsels in people with Bone Cyst, run by The Hospital for Sick Children at 25 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Bone Cyst
- What is being tested?
- Curettage with puncture (C & P), Curette and Vitoss morsels
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 25 sitesin 4 countries
- Study dates
- Mar 2015to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
25 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Project Manager contact
25 sites in 4 countries
United States11 sites, 4 recruiting
- Withdrawn
The John Hopkins Hospital
Baltimore, Maryland, 21287
- Withdrawn
Children's Hospital of Alabama
Birmingham, Alabama, 35233
- Recruiting
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Julie Titter, julie_titter@med.unc.edu
Anna Vergun
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Carly Strohbach, cstrohbach@luriechildrens.org
Jamie Burgess, jburgess@luriechildrens.org
- Completed
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Grace Anand, gxanand@texaschildrens.org
Vinitha R Shenava
- Recruiting
Loma Linda University
Loma Linda, California, 92354
Elisabeth Clarke, EAClarke@llu.edu
Martin Morrison III
- Withdrawn
Hospital for Joint Diseases
New York, New York, 10003
- Withdrawn
Hospital for Special Surgery
New York, New York, 10021
- Completed
The Children's Hospital at Montefiore
The Bronx, New York, 10467
- Completed
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Canada8 sites, 6 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Yoga Dhanapala, yndhanap@ucalgary.ca
Elaine Joughin
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Jennifer Hurry, Jennifer.Hurry@iwk.nshealth.ca
Karl Logan
- Recruiting
Children's Hospital at London Health Sciences Centre
London, Ontario, N6A 5W9
Jacob Davidson, Jacob.Davidson@lhsc.on.ca
Debra Bartley
- Completed
Shriners Hospital for Children - Canadian Unit
Montreal, Quebec, H3G 1A6
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Holly Livock, HLivock@cheo.on.ca
Sasha Carsen
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Julie Shiu, julie.shiu@sickkids.ca
Sevan Hopyan
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
Harpreet Chhina, HChhina@cw.bc.ca
HChhina@cw.bc.ca
- Withdrawn
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
United Kingdom5 sites, 5 recruiting
- Recruiting
Alder Hey Children's Hospital
Liverpool, L12 2AP
Emma Spink, emma.spink@alderhey.nhs.uk
Dan Perry
- Recruiting
Great Ormond Street Hospital for Children
London, WC1N 3JH
Kim Gardiner, kim.gardiner@gosh.nhs.uk
Andreas Roposch
- Recruiting
Royal Manchester Children's Hospital
Manchester, M13 9WL
Imelda Mayor, imelda.mayor@mft.nhs.uk
Mohamed Kenawey
- Recruiting
Nuffield Orthopaedic Centre
Oxford, OX3 7HE
Rebecca Harmer, rebecca.harmer@ouh.nhs.uk
Tim Theologis
- Recruiting
Sheffield Children's Hospital
Sheffield, S10 2TH
Aimee Corcoran, aimee.corcoran@nhs.net
Nicolas Nicolaou
Australia1 site, 1 recruiting
- Recruiting
The Royal Children's Hospital
Melbourne
Melissa Formosa, melissa.formosa@mcri.edu.au
Brian Loh
About this study
Official title: 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.
Read the 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:
- 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;
- to identify prognostic radiographic factors associated with simple bone cyst healing and fracture;
- to determine the impact of simple bone cyst on children/family functioning.
- Conditions
- Bone Cyst
- Being tested
- Curettage with puncture (C & P), Curette, Vitoss morsels
- Keywords
- Simple bone cyst, Unicameral bone cyst
- Medical subject headings
- Bone Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curettage with puncture (C & P)Procedure or surgery
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
CuretteDevice
A small surgical instrument with a rounded edge designed for scraping
Vitoss morselsDevice
Also called Tri-calcium phosphate bone graft substitute
A bone substitute intended for use as a filler for voids or gaps in bones
| Study group | Role | What they receive |
|---|---|---|
| C & P | Active comparator | Curettage with puncture (C \& P) will be performed alone Receives: 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) Receives: Procedure: Curettage with puncture (C & P); Device: Curette; Device: Vitoss morsels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyst healing
Healing will be graded according to a 4-point modified Neer's classification by radiologists
Measured: 2 years
Secondary outcomes (2)
Clinical measures (Cyst features)
Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
Measured: 1 and 2 years
Functional measures (Questionnaire scores)
Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startMar 2015
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bone CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, James Wright, The Hospital for Sick Children
- Investigators
- James G. Wright, Principal investigator, The Hospital for Sick ChildrenSevan Hopyan, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193841
- Sponsor's protocol ID
- 1000042364
- Acronym
- SBoCK
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2014
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18381307Donaldson 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.
PubMed 21191299Canavese 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.
PubMed 21150732Donaldson 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.
PubMed 21808696
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simple Bone Cysts in Kids (SBoCK)
- ClinicalTrials.gov ID
- NCT02193841
- Acronym / sponsor ID
- SBoCK / 1000042364
- Conditions
- Bone Cyst
- Keywords
- Simple bone cyst, Unicameral bone cyst
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2015
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- to identify prognostic radiographic factors associated with simple bone cyst healing and fracture;
- to determine the impact of simple bone cyst on children/family functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C & P | Active comparator | Procedure: Curettage with puncture (C & P), Device: CuretteCurettage with puncture (C \& P) will be performed alone |
| C & P with Vitoss | Active comparator | Procedure: Curettage with puncture (C & P), Device: Curette, Device: Vitoss morselsA predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P) |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | C & P, C & P with Vitoss |
| CuretteA small surgical instrument with a rounded edge designed for scraping | Device | C & P, C & P with Vitoss |
| Vitoss morselsAlso: Tri-calcium phosphate bone graft substituteA bone substitute intended for use as a filler for voids or gaps in bones | Device | C & P with Vitoss |
Primary outcome
Cyst healing
Time frame: 2 years
Healing will be graded according to a 4-point modified Neer's classification by radiologists
2 secondary outcomes
Clinical measures (Cyst features)
Time frame: 1 and 2 years
Functional measures (Questionnaire scores)
Time frame: 1 and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Background: PubMed 18381307Wright 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.
- Background: PubMed 21191299Donaldson 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.
- Background: PubMed 21150732Canavese 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.
- Background: PubMed 21808696Donaldson 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.
- SBoCK Trial WebsiteLink provided by the sponsor.
Related trials for Bone Cyst
Not yet recruiting
Osteogenic Potential of Topical Metformin Gel on Cystic Jaw Defects
Jaw Cysts, Metformin
Recruiting
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
Apical Periodontitis, Endodontically Treated Teeth
Active, not recruiting
Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
Impact Molar, Mandible Cyst
RecruitingObservational study
Familial Investigations of Childhood Cancer Predisposition
Acute Leukemia, Adenomatous Polyposis
RecruitingObservational study
Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts
Odontogenic Cysts, Odontogenic Keratocyst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Project Manager contact
James G. Wright principal investigator
The Hospital for Sick Children
Sevan Hopyan principal investigator
The Hospital for Sick Children
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Curettage with puncture (C & P), Curette and Vitoss morsels in people with Bone Cyst, run by The Hospital for Sick Children at 25 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada, United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (sbock.study@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cyst healing (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02193841, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.