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In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA)

NCT04113785 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2019-11-15

Study results available
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Summary

In vivo knee kinematics will be assessed for 20 subjects that have been implanted with a Total Joint Orthopedics Klassic knee system by Dr. Aaron Hofmann of the Hofmann Arthritis Institute's Center for Precision Joint Replacement. This is the location from which all participants will be recruited and where fluoroscopy data collection will occur. Participants will undergo fluoroscopic surveillance of their implanted knee using a C-arm fluoroscopic unit while performing a deep knee bend activity at least six months post-operatively.

Conditions

  • Total Knee Arthroplasty
  • Osteo Arthritis Knee
  • Knee Implant
  • Knee Injuries

Interventions

DEVICE

Klassic Knee System

At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee

Sponsors & Collaborators

  • Hofmann Arthritis Institute

    collaborator UNKNOWN

  • Duke University

    collaborator OTHER

  • The University of Tennessee, Knoxville

    lead OTHER

Principal Investigators

  • Richard Komistek, Ph.D. · The University of Tennessee

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2018-12-31
Completion
2019-06-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04113785 on ClinicalTrials.gov