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

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.

Study Overview

• Status: Completed
• Conditions: Knee Prosthesis
• Intervention / Treatment: Device: Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA); Device: Zimmer PCR TKA

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • Science and Engineering Research Facility
    • Knoxville, Tennessee, United States, 37996
      • Perkins Hall, The University of Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Tennessee Orthopaedic Clinic, Tennessee Orthopaedic Foundation for Education & Research
    • Knoxville, Tennessee, United States, 37996
      • Dougherty Engineering Building, Room M007

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be patients of Dr. Harold E. Cates of Tennessee Orthopaedic Clinics and must have been implanted with either a Stryker Triathlon CR TKA or Zimmer PCR TKA

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with a Stryker Triathlon CR TKA; Patients implanted with a Stryker Triathlon Posterior Cruciate Retaining Total Knee Arthroplasty.	Device: Stryker 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.; Other Names: Triathlon PCR TKA
Patients with a Zimmer PCR TKA; Patients implanted with a Zimmer NexGen Posterior Cruciate Retaining Total Knee Arthroplasty.	Device: Zimmer PCR 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.; Other Names: Zimmer NexGen PCR TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematics - Deep Knee Bend Activity	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	3 months post-operative
Kinematics - Ramp up Activity	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	3 months post-operative
Kinematics - Ramp Down Activity	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	3 months post-operative

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: Stryker Orthopaedics
• Investigators: Principal Investigator: Adrija Sharma, Ph D, The University of Tennessee; Principal Investigator: Richard D Komistek, Ph D, The University of Tennessee; Principal Investigator: William R Hamel, Ph D, The University of Tennessee; Principal Investigator: Harold E Cates, MD, Tennessee Orthopaedic Clinics

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 23, 2013
• First Posted (Estimate): May 29, 2013

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Knee Prosthesis; Cruciate Retaining; Posterior Cruciate Retaining
• Other Study ID Numbers: 130180/2012017; R011373454 (Other Grant/Funding Number: Stryker Orthopaedic)