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In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01864434
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : December 24, 2014
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
Richard Komistek, 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.

Condition or disease Intervention/treatment
Knee Prosthesis 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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: In Vivo Comparison of Kinematics for Patients Implanted With Either a Stryker or a Zimmer Posterior Cruciate Retaining Total Knee Arthroplasty
Study Start Date : June 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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 Name: 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 Name: Zimmer NexGen PCR TKA




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864434


Locations
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United States, Tennessee
Tennessee Orthopaedic Clinic, Tennessee Orthopaedic Foundation for Education & Research
Knoxville, Tennessee, United States, 37923
Dougherty Engineering Building, Room M007
Knoxville, Tennessee, United States, 37996
Perkins Hall, The University of Tennessee
Knoxville, Tennessee, United States, 37996
Science and Engineering Research Facility
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
The University of Tennessee, Knoxville
Stryker Orthopaedics
Investigators
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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

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Responsible Party: Richard Komistek, Principal Investigator, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT01864434     History of Changes
Other Study ID Numbers: 130180/2012017
R011373454 ( Other Grant/Funding Number: Stryker Orthopaedic )
First Posted: May 29, 2013    Key Record Dates
Results First Posted: December 24, 2014
Last Update Posted: October 10, 2019
Last Verified: October 2019
Keywords provided by Richard Komistek, The University of Tennessee, Knoxville:
Knee Prosthesis
Total Knee Arthroplasty
Cruciate Retaining
Posterior Cruciate Retaining