A Phase 3 interventional study of Curettage with puncture (C & P) and Curette in Bone Cyst, sponsored by The Hospital for Sick Children. Recruiting at 25 sites in 4 countries. Open to participants aged 2 Years to 21 Years. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by The Hospital for Sick Children · Phase 3, Interventional, and Treatment
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.
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:
18 studies on the registry are indexed under Bone Cysts; 5 are open to participants now.
This study's planned enrollment of 160 is above the median of 17 across 10 interventional studies indexed under Bone Cysts.
Browse Bone Cysts studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Curettage with puncture (C \& P) will be performed alone
Procedure: Curettage with puncture (C & P) · Device: Curette
A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)
Procedure: Curettage with puncture (C & P) · Device: Curette · Device: Vitoss morsels
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
Also known as: Tri-calcium phosphate bone graft substitute
Cyst healing
Healing will be graded according to a 4-point modified Neer's classification by radiologists
Time frame: 2 years
Clinical measures (Cyst features)
Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment
Time frame: 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
Time frame: 1 and 2 years
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The record gives a start of Mar 2015, a primary completion of Mar 2027 and a completion of Mar 2027. It does not say whether these dates are actual or estimated.
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