Purpose

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.

Condition

Eligibility

Eligible Ages
Between 2 Years and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Device: Curette
    A small surgical instrument with a rounded edge designed for scraping
  • Device: Vitoss morsels
    A bone substitute intended for use as a filler for voids or gaps in bones
    Other names:
    • Tri-calcium phosphate bone graft substitute
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
  • Device: Curette
    A small surgical instrument with a rounded edge designed for scraping
  • Device: Vitoss morsels
    A bone substitute intended for use as a filler for voids or gaps in bones
    Other names:
    • Tri-calcium phosphate bone graft substitute

Recruiting Locations

The Children's Hospital at Montefiore
Bronx, New York 10467
Contact:
Regina Hanstein
hanstein@montefiore.org

More Details

NCT ID
NCT02193841
Status
Recruiting
Sponsor
The Hospital for Sick Children

Study Contact

Julie Shiu
416-813-7654
julie.shiu@sickkids.ca

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.