Trident II Tritanium Acetabular Shell Outcomes Study
- Conditions
- Arthroplasty, Replacement, Hip
- Interventions
- Device: Trident II Tritanium Acetabular Shell
- Registration Number
- NCT02999009
- Lead Sponsor
- Stryker Orthopaedics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 383
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trident II Tritanium Acetabular Shell Trident II Tritanium Acetabular Shell -
- Primary Outcome Measures
Name Time Method Absence of Revision for the Trident II Tritanium Acetabular Shell 5 years
- Secondary Outcome Measures
Name Time Method Radiographic Stability 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years Numerous parameters will be reviewed by zone, including radiolucency and migration.
All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell 10 years Survivorship percentage (one reported value) for both all-cause revision + removal will be indicated
Trial Locations
- Locations (9)
Tucson Orthopaedic Institute
🇺🇸Tucson, Arizona, United States
Southeast Orthopedic Specialists
🇺🇸Jacksonville, Florida, United States
Rothman Institute
🇺🇸Egg Harbor Township, New Jersey, United States
American Hip Institute
🇺🇸Des Plaines, Illinois, United States
Center for Orthopaedics and Spine, LLC
🇺🇸Lake Charles, Louisiana, United States
St. Joseph Mercy Hospital Health System
🇺🇸Ypsilanti, Michigan, United States
UNC Orthopaedics
🇺🇸Chapel Hill, North Carolina, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Northwell Health, Lenox Hill Hospital
🇺🇸New York, New York, United States