Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT04169568
Eligibility Criteria:
Inclusion Criteria:
* Patients with OI who are undergoing extremity surgery or spinal fusion surgery.
* Patients between the ages of 1 and 35 years with OI who are admitted at our institution to a non-ICU inpatient setting in the postoperative period following an orthopedic surgery.
* Patients who initially require ICU-level care but transition to a non-ICU setting following an orthopedic surgery.
* Recent fracture in contralateral upper extremity (\< 8 weeks, or upper extremity fracture that is not yet completely healed).
* Must be able to tolerate upper extremity blood pressures.
* Medical clearance by OI physicians (Kruse, Franzone) after review of fracture history, surgical procedures, x-rays.
Exclusion Criteria:
* Parent or child refusal, uncooperative child.
* History of frequent upper extremity fracture on ipsilateral side, or recent upper extremity fracture on ipsilateral side if only that side may be used.
* Clinical presence of thrombocytopenia (excessive or easy bleeding or bruising), admission or transfer to PICU.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
35 Years
Study:
NCT04169568
Study Brief:
Protocol Section:
NCT04169568