NCT02373761

A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 27 (estimated)
• Sponsor: Scott Sporer · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to find out if the tibial and patellar components of the Stryker Triathlon Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.

Detailed description

Primary Hypothesis: The investigators expect the tibial and patellar components of the Stryker Triathlon Tritanium knee to achieve adequate fixation to the underlying bone. Secondary Hypotheses: The investigators expect that there will be no continuous migration between one and two years post-operative in the Triathlon Tritanium components. The investigators expect to see a correlation between radiolucent lines and migration characteristics using RSA. The investigators expect that inducible displacement exams taken at 2 years post-operative will be able to distinguish between patients identified by RSA measurements as having inadequate fixation. The investigators expect to see a significant difference in health status and functional outcomes before and after total knee replacement using the Triathlon Tritanium knee.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DEVICE	Stryker Triathlon Tritanium primary knee

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-02-01
• First posted: 2015-02-27
• Last updated: 2015-02-27

Locations

1 site across 1 country: United States