NCT03724058

Fixation and Stability of the Trident® II Clusterhole HA Shells

Fixation and Stability of the Trident® II Clusterhole HA Shells Compared to the Trident® Hemi HA Shells With X3. A Single Center RSA Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hip Replacement Arthroplasty

Interventions

Type	Name	Description
DEVICE	Trident® II Clusterhole HA Acetabular Shell	Hip arthroplasty
DEVICE	Trident® Hemispherical Acetabular Shell	Hip arthroplasty

Timeline

• Start date: 2019-02-06
• Primary completion: 2023-06-05
• Completion: 2031-05-11
• First posted: 2018-10-30
• Last updated: 2025-09-04

Locations

1 site across 1 country: Sweden