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Simple Bone Cysts in Kids (SBoCK)

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ClinicalTrials.gov Identifier: NCT02193841
Recruitment Status : Recruiting
First Posted : July 18, 2014
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
James Wright, 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.

Condition or disease Intervention/treatment Phase
Bone Cyst Procedure: Curettage with puncture (C & P) Device: Curette Device: Vitoss morsels Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Simple Bone Cysts in Kids (SBoCK)
Study Start Date : March 2015
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
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

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 Name: Tri-calcium phosphate bone graft substitute




Primary Outcome Measures :
  1. Cyst healing [ Time Frame: 2 years ]
    Healing will be graded according to a 4-point modified Neer's classification by radiologists


Secondary Outcome Measures :
  1. Clinical measures (Cyst features) [ Time Frame: 1 and 2 years ]
    Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment

  2. Functional measures (Questionnaire scores) [ Time Frame: 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



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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193841


Contacts
Contact: Brittany Barnes 416-813-7654 ext 228731 brittany.barnes@sickkids.ca
Contact: Julie Shiu 416-813-7654 ext 203156 julie.shiu@sickkids.ca

  Show 24 Study Locations
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: James G. Wright The Hospital for Sick Children
Principal Investigator: Sevan Hopyan The Hospital for Sick Children