Clinical Trials Directory

Trials / Completed

CompletedNCT01864434

In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty

In Vivo Comparison of Kinematics for Patients Implanted With Either a Stryker or a Zimmer Posterior Cruciate Retaining Total Knee Arthroplasty

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
The University of Tennessee, Knoxville · Academic / Other
Sex
All
Age
40 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This study will compare the kinematics data collected from patients with implants created by different manufacturers to see which of these implants provides a more normal-like kinematic pattern compared to the normal knee.

Detailed description

A better understanding of knee joint kinematics is important to explain premature polyethylene wear failures within knee implants and to help design a prosthesis that most closely approximates the normal knee. Therefore, the objectives for this study are to compare the in vivo kinematic patterns for subjects implanted with either a Stryker Triathlon Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) or Zimmer NexGen PCR TKA design to determine if there are any kinematic differences between these TKA designs. Each subject will be asked to undergo a fluoroscopic evaluation while performing weight-bearing activities under surveillance using the University of Tennessee's new mobile tracking fluoroscopic unit while performing deep knee bend and ramp up and ramp down activities. The mobile fluoroscopy unit is approved for use by the State of Tennessee on a study-by-study basis after IRB approval is obtained for each study.

Conditions

Interventions

TypeNameDescription
DEVICEStryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.
DEVICEZimmer PCR TKAThe fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.

Timeline

Start date
2013-06-01
Primary completion
2014-11-01
Completion
2014-11-01
First posted
2013-05-29
Last updated
2019-10-10
Results posted
2014-12-24

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01864434. Inclusion in this directory is not an endorsement.