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 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT06312995
Eligibility Criteria:
Inclusion Criteria:
* Patient aged between 7 and 13 years with compound fracture of the distal metaphysis of radius and/or ulna at "green wood" and initial angulation \<20°;
* Informed consent obtained.
Exclusion Criteria:
* Complete fracture of radius and ulna;
* Open fracture of radius and ulna;
* Polytrauma, polyfracture;
* Presence of neurovascular deficit at presentation;
* Presence of underlying bone disease;
* Presence of acute or chronic skin disorders;
* Psycho-behavioural disorders;
* Presence of ≥1 skin lesions according to NPUAP/EPUAP classification;
* Specific allergies related to the materials used in the tested device;
* Inability to perform follow-up examinations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
13 Years
Study:
NCT06312995
Study Brief:
Protocol Section:
NCT06312995