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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT07115732
Eligibility Criteria:
Inclusion Criteria:
* Patients deemed suitable for elective primary THR, as per indications in the IFU.
* Male or female, 18 years to 85 years.
Exclusion Criteria:
* Patients who are unable to provide written informed consent.
* Patients deemed unsuitable for THR, as per contra-indications in the IFU.
* Patients indicated for THR as a result of trauma (i.e. neck of femur fracture).
* Patients who are pregnant (exclusion criteria for THR in general).
* Patients receiving implants other than the approved combination, i.e. an ACE Acetabular Cup System with a JRI femoral stem and head.
* Patients who are unable to comply with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07115732
Study Brief:
Protocol Section:
NCT07115732