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Completed

NCT Number: NCT04113785

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

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.

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Key information

Conditions

Total Knee Arthroplasty Arthritis Joint Diseases Knee Implant Knee Injuries Leg Injuries Musculoskeletal Diseases Osteo Arthritis Knee Osteoarthritis Rheumatic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hofmann Arthritis Institute for Precision Joint Replacement

Salt Lake City, Utah, 84102, United States

About this study

Enrollment will be increased to 24 subjects to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. 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. The kinematics for the 20 knees will be analyzed, including condylar roll-back, axial rotation, range of motion, and condylar lift-off

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects will have a Klassic knee system.
  • Subjects must be at least six months post-operative.
  • Participants must be judged clinically successful with their most recent (new) Knee Society "Knee Score" equal to or greater than 80.
  • Participants must be able to perform a deep knee bend.
  • Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
  • Must speak English.

Exclusion criteria

  • Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
  • Subjects without the required type of knee implant.
  • Bilateral subjects (i.e., patients with both knees implanted)
  • Subjects who are unable to perform a deep knee bend.
  • Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
  • Subjects who do not speak English

Treatment and study plan

Klassic Knee System

Device

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

Primary outcomes

  1. Axial Rotation (AR) During Deep Knee Bend

    Time frame: at least 6 months post-operative

    Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.

  2. Maximum Weight-bearing Flexion During Deep Knee Bend

    Time frame: at least 6 months post-operative

    Maximum weight-bearing flexion that the subjects are able to achieve during deep knee bend. All values are positive.

  3. Medial Condyle Translations During Deep Knee Bend Activity.

    Time frame: at least 6 months post-operative

    Anterior Posterior (AP) translations of medial femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.

  4. Lateral Condyle Translations During Deep Knee Bend Activity

    Time frame: at least 6 months post-operative

    Anterior Posterior (AP) translations of lateral femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

  • Duke University
  • Hofmann Arthritis Institute

Registry information

Official study title

In Vivo Kinematics for Subjects Implanted With Klassic TKA

Acronym: TKA

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 3, 2019
Registry last updated
Nov 15, 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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