RecruitingPHASE3INTERVENTIONAL

Simple Bone Cysts in Kids

This research looks at simple bone cysts (SBCs), which are fluid-filled pockets that usually form in the long bones of children's arms or legs. While they are not cancerous, SBCs can cause pain, make it hard for children to play, and sometimes lead to bone fractures. There are many ways to treat these cysts, but doctors don't yet know if one method is clearly better than others. This study aims to compare two common surgical approaches to see which one is more effective at helping the cysts heal. We also want to understand how these cysts affect children and their families, ensuring we find the best ways to help young patients recover and get back to their normal activities.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

The Hospital for Sick Children

Enrolment target

160

Start

01 Mar 2015

Estimated completion

01 Mar 2027

Bone Cyst

What is this study about?

Simple bone cysts (SBCs) are fluid-filled pockets that often appear in children's arm or leg bones. Although they are not cancer, they can be painful, make it difficult for children to use their arm or leg properly, and sometimes lead to the bone breaking. Despite what some people might think, these cysts don't usually go away on their own once a child stops growing.

Doctors have tried many different treatments for SBCs over the years, but so far, no single treatment has been proven to consistently get rid of them for good. This can be frustrating for both children and their families, as the cysts can cause a lot of worry and disrupt a child's normal activities and play.

This study aims to provide clearer answers. We are comparing two common surgical treatments that doctors currently use. By doing this, we hope to understand which treatment helps the cysts heal better. We will also be looking at which features of the cysts might suggest how well they will heal and if a bone is likely to break. Importantly, we want to understand how simple bone cysts affect the daily lives of children and their families, so that future treatments can not only heal the cyst but also improve overall well-being.

Key takeaways

This study compares two common surgical treatments for non-cancerous bone cysts in children.
The goal is to find out which treatment helps cysts heal best and reduces pain.
Participation involves receiving one of the standard surgical treatments and follow-up care.
The study also aims to understand how these cysts impact children and families.
You can withdraw from the study at any time without affecting your child's future medical care.

Who may be eligible?

To join this study, children must have a simple bone cyst in a long bone (like an arm or leg bone) that was diagnosed within the last three months. If they've had a bone fracture in the past, at least three weeks must have passed since that fracture. Also, if they've had any previous treatment for the cyst, at least three months must have passed.

Children are not able to take part if they have certain other bone conditions, such as brittle bone disease or cancer, or if the cyst crosses the area where the bone grows (called the growth plate). Pregnant or breastfeeding females also cannot participate. Before joining, the child (if old enough) and their parents or guardians will need to understand the study and agree in writing to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is the person a child or young person aged 2 to 21 years?
Do they have a simple bone cyst in an arm or leg bone, diagnosed recently (within 3 months)?
Have at least 3 weeks passed since any bone fracture, and 3 months since any previous cyst treatment?
Are they not pregnant or breastfeeding (if applicable)?
Do they not have any other specific bone diseases (like cancer or brittle bones)?

Answer every question to see your result.

What does participation involve?

This study is comparing two surgical treatments for simple bone cysts. If you or your child takes part, you would receive one of these two standard treatments. This involves an operation where the surgeon either scrapes out the cyst and punctures it, or scrapes out the cyst, punctures it, and then injects a special substance called Vitoss morsels. Beyond the surgery itself, the study will involve follow-up appointments and assessments to monitor how well the cyst is healing and how your child is feeling. The total duration of participation will depend on the monitoring schedule, but is designed to evaluate healing over time.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving one of two established treatments for a simple bone cyst, potentially leading to healing and relief from pain. The study also helps improve our understanding of which treatments work best for children with these cysts, benefiting future patients. However, all surgical procedures carry potential risks, such as infection, bleeding, or issues related to anaesthesia, which will be fully explained by the medical team. There is also the possibility that the treatment may not be completely effective. We assure you that your participation is entirely voluntary, and you are free to withdraw from the study at any time without it affecting your child's medical care.

Locations (25)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Children's Hospital of Alabama
Verified postcode
Birmingham, United States· Withdrawn
Loma Linda University
Verified postcode
Loma Linda, United States· Recruiting
Nemours/Alfred I. duPont Hospital for Children
Verified postcode
Wilmington, United States· Completed
Ann & Robert H. Lurie Children's Hospital of Chicago
Verified postcode
Chicago, United States· Recruiting
The John Hopkins Hospital
Verified postcode
Baltimore, United States· Withdrawn
Hospital for Joint Diseases
Verified postcode
New York, United States· Withdrawn
Hospital for Special Surgery
Verified postcode
New York, United States· Withdrawn
The Children's Hospital at Montefiore
Verified postcode
The Bronx, United States· Completed
University of North Carolina - Chapel Hill
Verified postcode
Chapel Hill, United States· Recruiting
Cincinnati Children's Hospital Medical Center
Verified postcode
Cincinnati, United States· Completed
Texas Children's Hospital
Verified postcode
Houston, United States· Recruiting
The Royal Children's Hospital
Verified postcode
Melbourne, Australia· Recruiting

Common questions

What is a simple bone cyst?

It's a fluid-filled pocket that forms inside a bone, most often in the arms or legs of children. It's not cancerous.

Why is this study being done?

Doctors want to find out which of two common surgical treatments works best for simple bone cysts to help children recover better.

Will my child definitely get one of the treatments mentioned?

Yes, if your child qualifies and joins the study, they will receive one of the two surgical treatments being compared.

How long will my child need to be involved in the study?

The study involves following up on your child's healing after surgery. The exact duration will be explained by the study team.

Are there any risks to participating?

As with any surgery, there are potential risks like infection. These will be discussed in detail by the medical team before you decide to take part.

How to find out more

Project Manager

sbock.study@sickkids.ca Official trial record

Always speak to your GP or specialist before deciding to take part in a study.