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Simple Bone Cyst in Kids

Patient Enrolment

A detailed explanation of patient enrolment procedures can be found in the Manual of Operations and Procedures (MOOP). For a copy of the MOOP, please visit the Sharepoint website or contact the Central Coordinating Centre (CCC).

  1. Patients are identified during an inpatient or outpatient visit by their treating surgeon for interest in study participation.
  2. If the patient and/or their family are interested in discussing the trial, they will be approached by a member of the study team to begin the informed consent process.
  3. If the patient and/or their family agree to participate in the trial, they must sign the informed consent document as per local practice.
  4. Treating surgeon confirms patient eligibility and sign off the eligibility checklist. All testing to confirm eligibility must be completed prior to registration on study.Research staff must send via email or fax the signed eligibility checklist along with de-identified source documentation (including the signed informed consent page) to the CCC at SickKids.
  5. Once eligibility is confirmed by the CCC, they will register the patient on study. Patients should be registered at least 48 hours prior to treatment initiation.
  6. Patient will be randomized by the CCC to one of two treatment arms.
  7. The coordinating centre will send an email confirmation of patient’s registration and treatment allocation to the Principal Investigator, the patient’s treating surgeon, and site coordinator. This confirmation MUST be received prior to initiating protocol therapy or the patient will be declared ineligible.