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Simple Bone Cysts in Kids

PHASE3RECRUITING

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.

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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.

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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)
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    Eligibility

    Age eligible for study : 2 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2015-03-01

    Primary completion: 2027-03-01

    Study completion finish: 2027-03-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT02193841

    Intervention or treatment

    PROCEDURE: Curettage with puncture (C & P)

    DEVICE: Curette

    DEVICE: Vitoss morsels

    Conditions

    • Bone Cyst

    Find a site

    Closest Location:

    The Royal Children's Hospital

    Research sites nearby

    Select from list below to view details:

    • The Royal Children's Hospital

      Melbourne, Not Specified, Australia

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    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/ArmIntervention/Treatment
    ACTIVE_COMPARATOR: C & P
    • Curettage with puncture (C \& P) will be performed alone
    PROCEDURE: Curettage with puncture (C & P)
    • 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
    ACTIVE_COMPARATOR: C & P with Vitoss
    • A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)
    PROCEDURE: Curettage with puncture (C & P)
    • 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

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Cyst healingHealing will be graded according to a 4-point modified Neer's classification by radiologists2 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Clinical measures (Cyst features)Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment1 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 treatment1 and 2 years

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Simple Bone Cysts in Kids

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