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 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT06162195
Eligibility Criteria:
Inclusion Criteria:
* Patient requires unilateral primary hip arthroplasty due to primary osteoarthritis, osteoarthritis secondary to e.g. trauma, avascular necrosis or developmental hip dysplasia, or inflammatory arthritis.
* Patient is willing to comply with study requirements.
* Patient plans to be available through 10 years postoperative follow-up.
Exclusion Criteria:
* Patient has a BMI greater than 40 kg/m².
* Patient has active infection or sepsis (treated or untreated).
* Patient has insufficient bone stock at the hip (\>1/3 necrosis of the femoral head or large and multiple cysts) or in general as in severe osteopenia or osteoporosis (t-score \< -2.5 as measured with BMD).
* Patient is not skeletally mature.
* Patient meets the contraindication criteria of the control device.
* Patient already has another lower limb arthroplasty or arthrodesis or will require a further lower limb arthroplasty or arthrodesis within the subsequent 2 years.
* Patient lacks capacity to consent.
* Patient is unable to understand the native language of the country where their procedure is taking place
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06162195
Study Brief:
Protocol Section:
NCT06162195