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The purpose of the Trident® II project is to introduce a cup system that modernizes and streamlines Stryker's acetabular shell portfolio. The Trident® II Clusterhole HA Shell combines the history of Stryker's Trident® shells with plasma spray CpTi with HA coating. Plasma spray coating and HA is considered to be the gold standard in orthopaedics today. This coating will help the cup to achieve early stability and long term fixation.
One of the causes for implant failure is loosening and osteolysis. Osteolysis can be triggered when metal or polyethylene wear particles from the implant or bearing surfaces migrate between implant and surrounding host bone tissue. With the development of sequential irradiated and annealed highly crosslinked polyethylene (X3) wear rates (mean proximal, 2-dimensional and 3-dimensional) have been substantially reduced to 0.001 mm/y, calculated between 1 year and 5 years.
The Trident® II Clusterhole HA shells have a plasma sprayed CpTi coating compared to the arc-deposition CpTi coating on legacy Trident® shells, both designed to allow bone ongrowth. With this study the investigators want to prove equivalent implant fixation of both type of cups.
The primary objective is the assessment of prosthetic fixation and migration results after two years of the Trident® II Clusterhole HA shell compared to the legacy Trident® Hemi HA shell by means of RSA. It is hypothesized that they will perform equally.
The secondary outcome measure will be long-term (10-year) survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10-year results will be used to verify the predicted long-term survival results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trident® II Clusterhole HA Acetabular Shell | Experimental | Hip arthroplasty using Trident II Clusterhole HA Acetabular Shells |
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| Trident® Hemispherical Acetabular Shell | Active Comparator | Hip arthroplasty using Trident Hemispherical Acetabular Shell |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trident® II Clusterhole HA Acetabular Shell | Device | Hip arthroplasty |
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| Measure | Description | Time Frame |
|---|---|---|
| Migration, measured by means of RSA | Migration (MTPM in mm) of the prosthesis with respect to the host bone | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Migration, measured by means of RSA | Migration (MTPM in mm) of the prosthesis with respect to the host bone | 10 years |
| Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics Hässleholm-Kristianstad-Ystad, Hässleholm Hospital | Hässleholm | 28138 | Sweden |
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| Trident® Hemispherical Acetabular Shell | Device | Hip arthroplasty |
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The EQ-5D-3L consists of questions covering five dimensions measuring the patient's mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each question with three levels of possible answers and a single index value for health status. Health status has a range from 1 to 100.
| pre-operative, 3 months, 1, 2, 5, 7 and 10 years |
| Investigation of clinical performance and patient outcome with the Forgotten Joint Score (FJS) patient questionnaire. | The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The FJS uses a 5-grade Likert scale ranging from "Never" to "Mostly". The score has a range of 0-100. | 3 months, 1, 2, 5, 7 and 10 years |
| Investigation of the patients' opinion about their hip and associated problems with HOOS (Hip disability and Osteoarthritis Outcome Score). | HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The HOOS uses a 5-grade Likert scale and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | pre-operative, 3 months, 1, 2, 5, 7 and 10 years |
| Investigation of patient outcome with radiographic analysis | Plain radiographs will be obtained for assessment of fixation of the device. | pre-operative, 3 months, 1, 2, 5, 7 and 10 years |