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

The University of Tennessee, Knoxville4 sites in 1 country50 target enrollmentJune 2013

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

November 2014

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

The University of Tennessee, Knoxville

Responsible Party

Principal Investigator

Richard Komistek

Principal Investigator

The University of Tennessee, Knoxville

Eligibility Criteria

Inclusion Criteria

•Must be at least 3 months post-operative with no other surgical procedures conducted within the past 6 months
•Must have body weight of less than 250 lbs
•Must have Body Mass Index of less than 38
•Must be judged clinically successful with a Knee Society Score \>90
•Must have 100% post-operative passive flexion with no ligamentous laxity or pain
•Must be able to walk on level ground without aid of any kind
•Must be able to ascend and descend a ramp with a 10 degree incline with no assistance
•Must be willing to sign both Informed Consent and HIPAA forms
•Must be between 160 cm (5'3) and 193 cm (6'4) tall

Exclusion Criteria

•Pregnant or potentially pregnant females
•Unwilling to sign Informed Consent or HIPAA forms

Outcomes

Primary Outcomes

Kinematics - Ramp up Activity

Time Frame: 3 months post-operative

Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp up activity

Kinematics - Deep Knee Bend Activity

Time Frame: 3 months post-operative

Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity

Kinematics - Ramp Down Activity

Time Frame: 3 months post-operative

Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp down activity