Simple Bone Cysts in Kids
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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)
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT02193841
Intervention or treatment
PROCEDURE: Curettage with puncture (C & P)
DEVICE: Curette
DEVICE: Vitoss morsels
Conditions
- Bone Cyst
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
The Royal Children's Hospital
Select from list below to view details:
The Royal Children's Hospital
Melbourne, Australia
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Who is running the clinical trial?
The Hospital for Sick Children
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: C & P
| Procedure: Curettage with puncture (C & P), Device: Curette |
ACTIVE_COMPARATOR: C & P with Vitoss
| Procedure: Curettage with puncture (C & P), Device: Curette, Device: Vitoss morsels |
What is the study measuring?
Primary Outcome
| 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
| 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 |
References
Clinical Trials Gov: Simple Bone Cysts in KidsOther trials to consider
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