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NCT Number: NCT02193841

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.

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Key information

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Royal Children's Hospital, Melbourne, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Curettage with puncture (C & P)

Procedure

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

Curette

Device

A small surgical instrument with a rounded edge designed for scraping

Vitoss morsels

Device

A bone substitute intended for use as a filler for voids or gaps in bones

Other names: Tri-calcium phosphate bone graft substitute

Primary outcomes

  1. Cyst healing

    Time frame: 2 years

    Healing will be graded according to a 4-point modified Neer's classification by radiologists

Secondary outcomes

  1. Clinical measures (Cyst features)

    Time frame: 1 and 2 years

    Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment

  2. Functional measures (Questionnaire scores)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Project Manager

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Simple Bone Cysts in Kids (SBoCK)

Acronym: SBoCK

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2014
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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