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.
Brief Title
Simple Bone Cysts in Kids
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Email
sbock.study@sickkids.ca
Completion Date
Completion Date Type
Estimated
Conditions
Bone Cyst
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)
* 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)
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Simple bone cyst
Unicameral bone cyst
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
21 Years
Minimum Age
2 Years
NCT Id
NCT02193841
Org Class
Other
Org Full Name
The Hospital for Sick Children
Org Study Id
1000042364
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Simple Bone Cysts in Kids (SBoCK)
Primary Outcomes
Outcome Description
Healing will be graded according to a 4-point modified Neer's classification by radiologists
Outcome Measure
Cyst healing
Outcome Time Frame
2 years
Secondary Outcomes
Outcome Description
Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
Outcome Time Frame
1 and 2 years
Outcome Measure
Clinical measures (Cyst features)
Outcome Description
Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment
Outcome Time Frame
1 and 2 years
Outcome Measure
Functional measures (Questionnaire scores)
See Also Links
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
21
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jacob Schulz
Investigator Email
jschulz@montefiore.org
Investigator Phone