Simple Bone Cysts in Kids

Study Overview
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Brief Summary
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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
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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.

Official Title
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Simple Bone Cysts in Kids (SBoCK)

Conditions
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Bone Cyst

Intervention / Treatment
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* Procedure: Curettage with puncture (C & P)
* Device: Curette
* Device: Vitoss morsels


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C & P<br>Curettage with puncture (C & P) will be performed alone | Procedure: Curettage with puncture (C & P)<br>* 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<br>Device: Curette<br>* A small surgical instrument with a rounded edge designed for scraping<br>|
| Active Comparator: C & P with Vitoss<br>A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C & P) | Procedure: Curettage with puncture (C & P)<br>* 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<br>Device: Curette<br>* A small surgical instrument with a rounded edge designed for scraping<br>Device: Vitoss morsels<br>* A bone substitute intended for use as a filler for voids or gaps in bones<br>* Other names: Tri-calcium phosphate bone graft substitute;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cyst healing | Healing will be graded according to a 4-point modified Neer's classification by radiologists | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical measures (Cyst features) | Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment | 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 | 1 and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simple bone cyst, Unicameral bone cyst