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Completed

NCT Number: NCT01864434

In Vivo Kinematics Comparison of Stryker or Zimmer 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.

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Key information

Conditions

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dougherty Engineering Building, Room M007, Knoxville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)

Device

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

Zimmer PCR TKA

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

  • Stryker Orthopaedics

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 29, 2013
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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