Simple Bone Cysts in Kids (SBoCK)


Clinical Trial

Offered by: Nemours
Location: Delaware Valley

Trial Name

Simple Bone Cysts in Kids (SBoCK)

What is the trial about?

Simple bone cysts (SBC) are cysts filled with fluid that occur most frequently in the long bones (arms and legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose is to compare two common treatments that are used by surgeons today.

Who can participate?

If your child:

  • is between 2 to 21 years old
  • has a confirmed Simple Bone Cyst in a long bone on x-ray (i.e., arm or leg bone)
  • has not had a fracture in the last 6 weeks
  • has not been treated for his/her imple Bone Cyst in the last 3 months
  • does not have any implants that stabilize the bone at the site of the Simple Bone Cyst
  • does not have any type of bone disease
  • is not pregnant or breastfeeding
  • does not have a simple bone cyst crossing a growth plate

What is involved?

Your child will be in the study for approximately 2 years. Participants will be required to attend 4-5 hospital visits and answer 3 follow-up telephone calls during this time. Each visit may take up to 1 hour and each telephone call will take up approximately 5 to 10 minutes.

You will be asked to sign this informed consent document before any study related procedures are performed on your child. If you consent to have your child participate, he/she will need to have the following exams and procedures to find out if they can be in the study. Some of these exams and procedures are part of regular care and may be done even if your child does not join the study. If he/she had some of them recently, they may not need to be repeated. This will be up to the study surgeon.

Screening visit

  • We will review your child’s medical, surgical and treatment history.
  • We will document your child’s demographics (age, gender).
  • We will perform a pregnancy test in females of child bearing potential.
  • We will take X-rays (front and side) of the bone cyst site
    Your child/you will complete the Activities Scale for Kids - Performance (ASKp) questionnaire about your child’s activity level (research procedure).
  • Your child/you will complete the Brief Illness Perception Questionnaire (B-IPQ) about how the SBC is affecting your child (research procedure).
  • Your child will indicate his/her pain on the Oucher scale (research procedure).

Randomization

If your child is deemed eligible to participate and you consent to allow him/her to take part in the study, they will be randomized to one of two treatment groups. Randomization means your child’s treatment is determined by chance, like flipping a coin. You will not know and cannot select the treatment group to which your child is assigned.

Your child will be randomized to one of the following treatment groups:

  1. Curettage with puncture: a small surgical instrument (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.
  2. Curettage with puncture and injection with Vitoss morsels: a surgical instrument (curette) will be inserted to scrape the contents of the cyst and a hole in the cyst wall will be made near the bone marrow cavity; then a predetermined amount of Vitoss morsels (a bone substitute) will be injected into the cavity. Vitoss is a tri-calcium phosphate bone graft substitute, which helps to encourage new bone growth.

All treatments may be repeated once, with at least three months between treatments.

Visit for study treatment

  • Your child will be anesthetized (you will sign a separate surgical consent form for this) and then will receive the treatment to which he/she was randomized.
  • Your child will indicate his/her pain on the Oucher scale (research procedure).

Visit for repeat treatment (if required by your surgeon)

  • We will review your child’s medical, surgical and treatment history.
  • We will perform a pregnancy test in females of child bearing potential.
  • We will take X-rays (front and side) of the bone cyst site
    Your child/you will complete the ASKp questionnaire about your child’s activity level (research procedure).
  • Your child/you will complete the B-IPQ about how the SBC is affecting your child (research procedure).
  • Your child will indicate his/her pain on the Oucher scale (research procedure).

Follow up phone calls

We will call you to ask how your child is doing at the following time points:

  • 30 days after treatment (research procedure)
  • 6 months after treatment (research procedure)
  • 18 months after treatment (research procedure)

Contact Nemours Clinical Trials

Trial Name:
Simple Bone Cysts in Kids (SBoCK)

IRB: 615612

Contact Information

(800) 354-5690
ClinicalTrials@nemours.org