Trident II Tritanium Acetabular Shell Outcomes Study (NCT02999009) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Trident II Tritanium Acetabular Shell Outcomes Study
United States383 participantsStarted 2017-01-20
Plain-language summary
The purpose of this study is to review the performance and success rate of an FDA approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
A. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
B. Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation.
C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.
D. Patient is a candidate for a primary cementless total hip replacement.
E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
Exclusion Criteria:
F. Patient has a Body Mass Index (BMI) ≥ 40.
G. Patient is diagnosed with Inflammatory Arthritis.
H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
I. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
J. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
K. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
L. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
M. Patient has had previous open surgery to the affected joint, not including arthroscopy.
N. Patient requires implantation of a constrained liner.
O. Patient has a known sensitivi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absence of Revision for the Trident II Tritanium Acetabular Shell