In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-11-30

Brief Summary

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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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Detailed Description

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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

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Knee Prosthesis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with a Stryker Triathlon CR TKA

Patients implanted with a Stryker Triathlon Posterior Cruciate Retaining Total Knee Arthroplasty.

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

Intervention Type 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.

Patients with a Zimmer PCR TKA

Patients implanted with a Zimmer NexGen Posterior Cruciate Retaining Total Knee Arthroplasty.

Zimmer PCR TKA

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Triathlon PCR TKA Zimmer NexGen PCR TKA

Eligibility Criteria

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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