Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-13 @ 1:55 PM
Study NCT ID:
NCT03724058
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2018-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixation and Stability of the Trident® II Clusterhole HA Shells
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: