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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT04191733
Eligibility Criteria:
Inclusion Criteria:
1. The patient is undergoing a standard of care primary cementless hip replacement with the Pinnacle cup and a Corail or Actis stem via the Anterior Advantage approach. All devices are to be used according to the approved indications.
2. Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.
3. Individuals who are willing and able to complete follow-up visits and questionnaires as specified by the study protocol.
4. Individuals who are not bedridden per the discretion of the investigator (The intent of "not bedridden" means a permanent situation, not a temporary situation as in a hip fracture or trauma case).
5. Individuals who are a minimum age of 21 years at the time of consent.
Exclusion Criteria:
1. Active local or systemic infection.
2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
3. Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
4. Charcot's or Paget's disease.
5. The Subject is a woman who is pregnant or lactating.
6. Subject had a contralateral amputation.
7. Previous partial hip replacement in affected hip.
8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
9. Contralateral hip was replaced less than 3 months prior to surgery date, contralateral hip is already enrolled in the study, or simultaneous or staged hip replacement is planned
10. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
11. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
12. Subject has a medical condition with less than 2 years of life expectancy.
13. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a physical or psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04191733
Study Brief:
Protocol Section:
NCT04191733