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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT05591859
Eligibility Criteria:
Inclusion Criteria:
* Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell.
* Subject has signed an IRB-approved, study specific Informed Consent Form (ICF).
* Subject is skeletally mature.
* Subject is a male or non-pregnant female.
* Subject is willing and able to comply with postoperative scheduled clinical evaluations.
Exclusion Criteria:
* Subject has a non-Stryker retained stem at the time of study device implantation.
* Subject has a Body Mass Index (BMI) \> 45.
* Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
* Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
* Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
* Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. \> 30 days).
* Subject has a known sensitivity to device materials.
* Subject is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05591859
Study Brief:
Protocol Section:
NCT05591859