NCT02155712

Triathlon Tritanium Knee Outcomes Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 680 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DEVICE	Triathlon Tritanium Knee	Cementless
DEVICE	Triathlon Knee	Cemented

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-04-05
• Completion: 2023-03-11
• First posted: 2014-06-04
• Last updated: 2023-11-14
• Results posted: 2019-07-16

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study