Simple Bone Cysts in Kids
- Conditions
- Bone Cyst
- Interventions
- Procedure: Curettage with puncture (C & P)Device: CuretteDevice: Vitoss morsels
- Registration Number
- NCT02193841
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- 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:
1. 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;
2. to identify prognostic radiographic factors associated with simple bone cyst healing and fracture;
3. to determine the impact of simple bone cyst on children/family functioning.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C & P with Vitoss Curette A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P) C & P Curette Curettage with puncture (C \& P) will be performed alone C & P Curettage with puncture (C & P) Curettage with puncture (C \& P) will be performed alone C & P with Vitoss Curettage with puncture (C & P) A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P) C & P with Vitoss Vitoss morsels A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)
- Primary Outcome Measures
Name Time Method Cyst healing 2 years Healing will be graded according to a 4-point modified Neer's classification by radiologists
- Secondary Outcome Measures
Name Time Method Functional measures (Questionnaire scores) 1 and 2 years Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment
Clinical measures (Cyst features) 1 and 2 years Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
Trial Locations
- Locations (25)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Nemours/Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
The John Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
The Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States
Hospital for Joint Diseases
🇺🇸New York, New York, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
The Royal Children's Hospital
🇦🇺Melbourne, Australia
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Winnipeg Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Children's Hospital at London Health Sciences Centre
🇨🇦London, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Shriners Hospital for Children - Canadian Unit
🇨🇦Montreal, Quebec, Canada
Alder Hey Children's Hospital
🇬🇧Liverpool, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, United Kingdom
Nuffield Orthopaedic Centre
🇬🇧Oxford, United Kingdom
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, United Kingdom
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
BC Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States