Comparing treatments for simple bone cysts in children
Simple Bone Cysts in Kids (SBoCK)
This study is testing which treatment works better for simple bone cysts in children: one that uses a curettage and puncture alone or one that adds an injection of Vitoss morsels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 2 Years to 21 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 25 sites (Birmingham, Alabama and 24 other locations) |
| Trial ID | NCT02193841 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two common treatments for simple bone cysts (SBCs) in children, specifically curettage with puncture alone versus curettage with puncture followed by injection with Vitoss morsels. SBCs are fluid-filled cysts that commonly occur in the long bones of children and can cause pain and functional limitations. The study will assess the rate of radiographic healing, identify prognostic factors associated with healing and fractures, and evaluate the impact of SBCs on children and their families. By utilizing a network of surgeons and researchers, the trial seeks to provide evidence-based insights into the best treatment options for SBCs.
Who should consider this trial
Good fit: Ideal candidates for this study are children with a confirmed simple bone cyst in a long bone who have not received treatment in the last three months.
Not a fit: Patients with underlying bone diseases or those with cysts crossing the growth plate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for children suffering from simple bone cysts, improving their quality of life.
How similar studies have performed: While few randomized clinical trials have focused on simple bone cysts, this study aims to fill a gap in the existing literature and provide valuable comparative data.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Birmingham, Alabama and 24 other locations
- Children's Hospital of Alabama — Birmingham, Alabama, United States (Withdrawn)
- Loma Linda University — Loma Linda, California, United States (Recruiting)
- Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States (Completed)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- The John Hopkins Hospital — Baltimore, Maryland, United States (Withdrawn)
- Hospital for Joint Diseases — New York, New York, United States (Withdrawn)
- Hospital for Special Surgery — New York, New York, United States (Withdrawn)
- The Children's Hospital at Montefiore — The Bronx, New York, United States (Completed)
- University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Completed)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- The Royal Children's Hospital — Melbourne, Australia (Recruiting)
- Alberta Children's Hospital — Calgary, Alberta, Canada (Recruiting)
- BC Children's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- Winnipeg Health Sciences Centre — Winnipeg, Manitoba, Canada (Withdrawn)
- IWK Health Centre — Halifax, Nova Scotia, Canada (Recruiting)
- Children's Hospital at London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (Recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
- Shriners Hospital for Children - Canadian Unit — Montreal, Quebec, Canada (Completed)
- Alder Hey Children's Hospital — Liverpool, United Kingdom (Recruiting)
- Great Ormond Street Hospital for Children — London, United Kingdom (Recruiting)
- Royal Manchester Children's Hospital — Manchester, United Kingdom (Recruiting)
- Nuffield Orthopaedic Centre — Oxford, United Kingdom (Recruiting)
- Sheffield Children's Hospital — Sheffield, United Kingdom (Recruiting)
Study contacts
- Principal investigator: James G. Wright — The Hospital for Sick Children
- Study coordinator: Project Manager
- Email: sbock.study@sickkids.ca
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.