Trident II Tritanium Acetabular Shell
DeviceA hemispherical acetabular shell indicated for cementless application.
NCT Number: NCT02999009
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.
This study is active but is not currently recruiting participants.
18 year–80 year
All sexes
Interventional
Not applicable
Tucson Orthopaedic Institute, Tucson, Arizona, United States
This study is a prospective, open-label, post-market, non-randomized evaluation of the Trident II Tritanium Acetabular Shell for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 sensitivity to device materials.
P. Patient is a prisoner.
A hemispherical acetabular shell indicated for cementless application.
Time frame: 5 years
To demonstrate that acetabular replacement with the Trident II Tritanium Acetabular Shell provides clinical results comparable to similar acetabular components.
Time frame: 10 years
Survivorship percentage (one reported value) for both all-cause revision + removal will be indicated
Time frame: 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years
Numerous parameters will be reviewed by zone, including radiolucency and migration.
Stryker Orthopaedics
Industry
A Prospective, Post-market, Multi-center Study of the Trident II Tritanium Acetabular Shell
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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