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:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT06108934
Eligibility Criteria:
Inclusion Criteria:
* The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Patient Information Consent Form for the use of the study device
* Primary non-inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis) and/or rheumatoid arthritis
* The patient is a candidate for a primary cementless THA.
* Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.
Exclusion Criteria:
* Active or suspected latent infection in or about the affected hip joint and the time of study device implantation.
* Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in post-operative care.
* Has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
* Is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \>30 days.)
* Requires revision THA or hip fusion to the affected joint.
* Has known sensitivity to device materials.
* Any involvement in an active Workers' Compensation investigation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06108934
Study Brief:
Protocol Section:
NCT06108934