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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT06204068
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Diagnosed with DDH
* Require closed reduction of the hip and hip spica casting
1. between 6-18 months old
2. Alpha angle \<60 degrees, beta angle \>55 degrees
i. Alpha angle is an angle created by lines along bony acetabulum and the ilium, normal is \>60 degrees
ii. Beta angle is an angle created by lines along the labrum and ilium, normal is \<55 degrees
c.Have either failed Pavlik harness or have dislocated hip on imaging
Exclusion Criteria:
* Patients over the age of 18 months
* Patients with DDH who do not require closed reduction surgery
* Patients with DDH who are initially consented for closed reduction surgery but their intraoperative findings necessitate conversion to open surgery
* Families that do not want to participate in the study
* Patients with dysplasia that need open reduction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Months
Maximum Age:
18 Months
Study:
NCT06204068
Study Brief:
Protocol Section:
NCT06204068