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Sponsor study identifier
interventional
87
1 country
1
Study Start
February 6, 2019
Actual (reported)Primary Completion
June 5, 2023
Actual (reported)Study Completion
May 11, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 11, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 26, 2018
Actual (reported)October 30, 2018
Actual (reported)February 6, 2019
Actual (reported)June 5, 2023
Actual (reported)May 11, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Migration, measured by means of RSA
Migration (MTPM in mm) of the prosthesis with respect to the host bone
2 years
Migration, measured by means of RSA
10 years
Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire
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.
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).
pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of patient outcome with radiographic analysis
pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Hip arthroplasty using Trident II Clusterhole HA Acetabular Shells
Hip arthroplasty using Trident Hemispherical Acetabular Shell
Hip arthroplasty
Hip arthroplasty
Department of Orthopaedics Hässleholm-Kristianstad-Ystad, Hässleholm Hospital
Hässleholm, 28138, Sweden
87 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2018
First Posted
October 30, 2018
Study Start
February 6, 2019
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 5, 2023
Actual (reported)Study Completion
May 11, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 4, 2025
Record last verified: 2025-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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