Triathlon Tritanium Knee Outcomes Study

Status Terminated

Clinical Trial Summary

The success of the Triathlon Tritanium Knee will be determined by comparing the rate of absence of revision for aseptic loosening of the tibial baseplate at 2 years with the rates reported in the literature.

Clinical Trial Description

Cases are to be enrolled at five to ten centers. The same center may be included in both arms. Conversely, a center may choose to participate in only a single arm. The enrollment goal is approximately 36 - 72 cases per center for Cohort 1 (cementless) and 15 - 30 cases per center for Cohort 2 (cemented) , and will vary dependent upon the number of participating centers. Although a goal is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the enrollment goal, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) or Ethics Committee (EC) approval. Non-compliance of a study center may result in termination of the center's participation in the study. ;

Study Design

Related Conditions & MeSH terms

Arthroplasty, Replacement, Knee

Clinical Trial Details

NCT number	NCT02155712
Study type	Interventional
Source	Stryker Orthopaedics
Contact
Status	Terminated
Phase	N/A
Start date	October 2014
Completion date	March 11, 2023

View Details

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