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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT05773261
Eligibility Criteria:
Inclusion Criteria:
* Patients are foreseen for implantation of an uncemented acetabular press-fit cup and an uncemented stem
* Age 30-70 years
* Primary osteoarthritis of the hip
* Body Mass Index between 18 and 35 kg/m2
* Willingness and ability to follow clinical investigation protocol
Exclusion Criteria:
* Grossly abnormal hip anatomy (hip dysplasia, Crowe Grade 2 or above, Perthes or other causes)
* Osteoporosis
* Paget's disease
* Inflammatory arthritis
* Secondary osteoarthritis
* Presence of malignancy in the area of surgery
* Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months or less prior to surgery
* Previous surgery in the affected hip
* Inclusion of the contralateral hip in this clinical investigation
* Not suited for the clinical investigation for other reason (surgeon's judgment)
* Pregnant or breastfeeding women
* Prison inmate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT05773261
Study Brief:
Protocol Section:
NCT05773261