Curettage with puncture (C & P)
ProcedureA 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
NCT Number: NCT02193841
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.
Interested in participating?
Request Info2 year–21 year
All sexes
Interventional
Phase 3
The Royal Children's Hospital, Melbourne, Australia
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
A small surgical instrument with a rounded edge designed for scraping
A bone substitute intended for use as a filler for voids or gaps in bones
Other names: Tri-calcium phosphate bone graft substitute
Time frame: 2 years
Healing will be graded according to a 4-point modified Neer's classification by radiologists
Time frame: 1 and 2 years
Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
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
Contact information is provided by the study sponsor or research team.
The Hospital for Sick Children
Other
Simple Bone Cysts in Kids (SBoCK)
Acronym: SBoCK
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View the official ClinicalTrials.gov record (opens in a new tab)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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