Simple Bone Cysts in Kids

Phase 3

Recruiting

• Conditions: Bone Cyst
• Interventions: Procedure: Curettage with puncture (C & P); Device: Curette; Device: Vitoss morsels

• Registration Number: NCT02193841
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Study Start: 2015-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C & P with Vitoss	Curette	A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)
C & P	Curette	Curettage with puncture (C \& P) will be performed alone
C & P	Curettage with puncture (C & P)	Curettage with puncture (C \& P) will be performed alone
C & P with Vitoss	Curettage with puncture (C & P)	A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)
C & P with Vitoss	Vitoss morsels	A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)

Primary Outcome Measures

Name	Time	Method
Cyst healing	2 years	Healing will be graded according to a 4-point modified Neer's classification by radiologists

Secondary Outcome Measures

Name	Time	Method
Functional measures (Questionnaire scores)	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
Clinical measures (Cyst features)	1 and 2 years	Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment

Trial Locations

Locations (25)

Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States

Loma Linda University; 🇺🇸 Loma Linda, California, United States

Nemours/Alfred I. duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

The John Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

The Children's Hospital at Montefiore; 🇺🇸 Bronx, New York, United States

Hospital for Joint Diseases; 🇺🇸 New York, New York, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

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