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Completed

NCT Number: NCT02613338

Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System - Phase 2

A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Specifically, posterior stabilizing (PS) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. To understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. This continuation of the study will analyze 30 subjects with the Attune PS FB 3 months post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend.

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Key information

Conditions

Total Knee Arthroplasty Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OrthoCarolina Research Institute, Charlotte, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least three (3) months post-operative with no other surgical procedures conducted within the past six months
  • Between 30-80 years of age
  • Body weight of less than 280 lbs
  • Must be between 160cm (5'3) and 193cm (6'4) tall
  • Body Mass Index (BMI) >18.5 and <35
  • Judged clinically successful with a Knee Society score (KSS) of greater than 80
  • Have good-to-excellent post-operative passive flexion with no ligamentous laxity or pain
  • Must be able to walk on level ground without aid of any kind, perform a ramp descent, and a deep knee bend (DKB), all without assistance
  • Will have a DePuy Attune PS TKA

Exclusion criteria

  • Pregnant or potentially pregnant females will be excluded from the study.

Treatment and study plan

DePuy Attune posterior stabilizing fixed bearing knee system

Device

Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.

Primary outcomes

  1. Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion

    Time frame: 3 months post-operative

    Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down

  2. Femoro-tibial Kinematics - Medial Anterior/Posterior Motion

    Time frame: 3 months post-operative

    Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down

  3. Femoro-tibial Kinematics - Axial Rotation

    Time frame: 3 months post-operative

    Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia.

  4. Femoro-tibial Kinematics - Weight-bearing Flexion

    Time frame: 3 months post-operative

    Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude.

Secondary outcomes

  1. Max Ground Reaction Force - Deep Knee Bend

    Time frame: 3 months post-operative

    Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the activity was normalized with respect to participant's body weight and has been termed "maximum reaction force."

  2. Max Ground Reaction Force - Gait

    Time frame: 3 months post-operative

    Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the activity.

    was normalized with respect to participant's body weight and has been termed "maximum reaction force."

  3. Max Ground Reaction Force - Ramp Down

    Time frame: 3 months post-operative

    Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the activity.

    was normalized with respect to participant's body weight and has been termed "maximum reaction force."

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

  • DePuy Synthes

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Nov 24, 2015
Registry last updated
Nov 12, 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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