Clinical Trial: Simple Bone Cysts in Kids

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Simple Bone Cysts in Kids (SBoCK)

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.

Detailed Summary:

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.

Sponsor: The Hospital for Sick Children

Current Primary Outcome: Cyst healing [ Time Frame: 2 years ]

Healing will be graded according to a 4-point modified Neer's classification by radiologists


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: July 4, 2014
Date Started: March 2015
Date Completion: September 2018
Last Updated: January 24, 2017
Last Verified: January 2017