| NCT ID | NCT02193841 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The Hospital for Sick Children |
| Condition | Bone Cyst |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2015-03 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2015-03 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Project Manager
✉ sbock.study@sickkids.caJames G. Wright
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT02193841 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 21 Years, studying Bone Cyst. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02193841 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT02193841 currently recruiting?
Yes, NCT02193841 is actively recruiting participants. Contact the research team at sbock.study@sickkids.ca for enrollment information.
Where is the NCT02193841 trial being conducted?
This trial is being conducted at Birmingham, United States, Loma Linda, United States, Wilmington, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT02193841 clinical trial?
NCT02193841 is sponsored by The Hospital for Sick Children. The principal investigator is James G. Wright at The Hospital for Sick Children. The trial plans to enroll 160 participants.