Status:

COMPLETED

Impact of Component Design and Fixation in Total Knee Arthroplasty

Lead Sponsor:

Washington University School of Medicine

Collaborating Sponsors:

Stryker Nordic

Conditions:

Arthroplasties, Knee Replacement

Eligibility:

All Genders

18-75 years

Brief Summary

The purpose of this study is to determine implant design and determine if method of fixation cemented versus cementless results in different bone loss patterns. The investigators also want to determin...

Detailed Description

Patients who present to the clinical practices of Dr. Ryan Nunley and Dr. Robert Barrack and are suitable candidates for primary total knee arthroplasty(TKA) type assigned either cemented or cementles...

Eligibility Criteria

Inclusion

  • Patients who qualify for a Primary Total knee using Triathlon Implant(thin tray) or Depuy Attune(thick tray) Implant
  • 18-75 years of age
  • Willing to sign informed consent
  • Willing to return for all follow-up visits

Exclusion

  • Patients with inflammatory arthritis
  • BMI \> 40
  • Patient with an active infection or suspected infection in the joint
  • Patient who have undergone osteotomy
  • Patients who have a previous diagnosis of osteopenia/osteoporosis or patients with weak bones and/or currently on medications to increase bone density/who have poor bone quality
  • Patients who have had previous patella fracture or surgery
  • Patients who have had previous knee or hip replacement surgery on the ipsilateral side
  • Patients who require patellar resurfacing
  • Patient with major medical/muscular/orthopedic deformities
  • Unable to undergo DEXA scanning.
  • Female patients of childbearing potential and an interest in getting pregnant in the future \*NOTE: Patients receiving simultaneous bilateral total knee arthroplasties are eligible. Both knees are eligible for enrollment as long as all other inclusion/exclusion criteria are met for each knee. If only one knee is eligible it will be included. Patients receiving staged bilaterals are also eligible, provided that each knee meets the inclusion exclusion criteria.

Key Trial Info

Start Date :

November 20 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 15 2021

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT03272178

Start Date

November 20 2017

End Date

November 15 2021

Last Update

December 1 2021

Active Locations (1)

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Washington University School of Medicine

St Louis, Missouri, United States, 63110

Impact of Component Design and Fixation in Total Knee Arthroplasty | DecenTrialz