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Procedure

Surgical Treatments for Bone Cysts (SBoCK Trial)

Phase 3
Recruiting
Led By James G. Wright
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years
Awards & highlights

SBoCK Trial Summary

This trial is testing two common treatments for simple bone cysts to see which is more effective.

Who is the study for?
This trial is for kids with simple bone cysts in their arms or legs. They must have had the cyst confirmed within the last 3 months and not treated it recently. Kids who've had a fracture need to wait at least 3 weeks before joining. It's not for pregnant teens, those breastfeeding, or anyone with other bone diseases.Check my eligibility
What is being tested?
The study compares two treatments: 'Curettage with puncture' where surgeons scrape out the cyst and make a hole for drainage, and using 'Vitoss morsels', which are synthetic bone graft materials placed into the cavity after scraping.See study design
What are the potential side effects?
Possible side effects may include pain at the surgery site, swelling, infection risk from surgery, reaction to anesthesia during procedure, and potential damage to surrounding bone tissue.

SBoCK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a confirmed simple bone cyst in my arm or leg diagnosed in the last 3 months.
Select...
It has been over 3 weeks since my last bone fracture.
Select...
I have implants stabilizing the bone where my cyst is.
Select...
It has been over 3 months since my last cyst treatment.

SBoCK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cyst healing
Secondary outcome measures
Clinical measures (Cyst features)
Functional measures (Questionnaire scores)

SBoCK Trial Design

2Treatment groups
Active Control
Group I: C & PActive Control2 Interventions
Curettage with puncture (C & P) will be performed alone
Group II: C & P with VitossActive Control3 Interventions
A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C & P)

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
683 Previous Clinical Trials
6,944,834 Total Patients Enrolled
1 Trials studying Bone Cysts
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,948 Total Patients Enrolled
James G. WrightPrincipal InvestigatorThe Hospital for Sick Children

Media Library

Curettage with puncture (C & P) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02193841 — Phase 3
Bone Cysts Clinical Trial 2023: Curettage with puncture (C & P) Highlights & Side Effects. Trial Name: NCT02193841 — Phase 3
Bone Cysts Research Study Groups: C & P, C & P with Vitoss
Curettage with puncture (C & P) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02193841 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research exclude patients who are over a certain age?

"This upcoming clinical trial is including patients that fall between the ages of 2 to 21 years old. Out of the 4 studies being conducted, 15 are for patients that are over the age of 18."

Answered by AI

Are there any available positions for participants in this trial?

"Yes, this study is still recruiting patients according to the most recent update on clinicaltrials.gov. The original posting was on 2015-03-01, with the last update being on 2022-05-03."

Answered by AI

How many test subjects are included in the scope of this research?

"In order to run this study, 160 volunteers that meet the given inclusion criteria are required. These potential participants can come from various locations, such as The John Hopkins Hospital in Baltimore, Maryland and Loma Linda University in Loma Linda, California."

Answered by AI

Is the Food and Drug Administration aware of the benefits of C & P?

"C & P's safety is supported by previous clinical data, so it was given a score of 3."

Answered by AI

Are there clinical research sites in more than one state for this trial?

"There are many hospitals and clinics taking part in this trial, with 14 different locations available in total. Some notable institutions include The John Hopkins Hospital in Baltimore, Loma Linda University in Loma Linda, and University of North carolina - Chapel Hill in Chapel Hill."

Answered by AI

Could I qualify to take part in this research?

"Children aged 2-21 with bone cysts are encouraged to participate in this study. Up to 160 patients will be admitted on the condition that 3 weeks have passed since their last fracture and 3 months have passed since their last cyst treatment."

Answered by AI
~39 spots leftby Mar 2027