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Clinical Trials/NCT02204748
NCT02204748
Completed
N/A

Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty

The University of Tennessee, Knoxville2 sites in 1 country5 target enrollmentNovember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
The University of Tennessee, Knoxville
Enrollment
5
Locations
2
Primary Endpoint
Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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 pilot study will analyze 5 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. Since this is a pilot study, there is no hypothesis.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
August 2015
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The University of Tennessee, Knoxville
Responsible Party
Principal Investigator
Principal Investigator

Richard Komistek

Principal Investigator

The University of Tennessee, Knoxville

Eligibility Criteria

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
  • Must be willing to sign the Informed Consent (IC) and HIPAA forms to participate in the study

Exclusion Criteria

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

Outcomes

Primary Outcomes

Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down

Time Frame: 3 months post-operative

Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.

Femoro-tibial Kinematics - Gait

Time Frame: 3 months post-operative

Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.

Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend

Time Frame: 3 months post-operative

Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.

Femoro-tibial Kinematics: Translation and Lift-off for Gait

Time Frame: 3 months post-operative

Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.

Femoro-tibial Kinematics - Deep Knee Bend

Time Frame: 3 months post-operative

Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.

Femoro-tibial Kinematics - Ramp Down

Time Frame: 3 months post-operative

Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.

Secondary Outcomes

  • Max Ground Reaction Force - Deep Knee Bend(3 months post-operative)
  • Max Ground Reaction Force - Ramp Down(3 months post-operative)
  • Max Ground Reaction Force - Gait(3 months post-operative)

Study Sites (2)

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