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In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty

Completed
Conditions
Knee Prosthesis
Interventions
Device: Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)
Device: Zimmer PCR TKA
Registration Number
NCT01864434
Lead Sponsor
The University of Tennessee, Knoxville
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients with a Stryker Triathlon CR TKAStryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)Patients implanted with a Stryker Triathlon Posterior Cruciate Retaining Total Knee Arthroplasty.
Patients with a Zimmer PCR TKAZimmer PCR TKAPatients implanted with a Zimmer NexGen Posterior Cruciate Retaining Total Knee Arthroplasty.
Primary Outcome Measures
NameTimeMethod
Kinematics - Ramp up Activity3 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 Activity3 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 Activity3 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

Dougherty Engineering Building, Room M007

🇺🇸

Knoxville, Tennessee, United States

Perkins Hall, The University of Tennessee

🇺🇸

Knoxville, Tennessee, United States

Science and Engineering Research Facility

🇺🇸

Knoxville, Tennessee, United States

Tennessee Orthopaedic Clinic, Tennessee Orthopaedic Foundation for Education & Research

🇺🇸

Knoxville, Tennessee, United States

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