Arthroplasty, Replacement, Hip
Conditions
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
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.
Interventions
DEVICETrident II Tritanium Acetabular Shell
A hemispherical acetabular shell indicated for cementless application.
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Revision for the Trident II Tritanium Acetabular Shell | 5 years | To demonstrate that acetabular replacement with the Trident II Tritanium Acetabular Shell provides clinical results comparable to similar acetabular components. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Radiographic Stability | 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years | Numerous parameters will be reviewed by zone, including radiolucency and migration. |
Countries
United States
Contacts
STUDY_DIRECTORKevin Barga
Director, Clinical Research - Stryker Joint Replacement
Outcome results
None listed