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Clinical Trials/NCT03033940
NCT03033940
Completed
N/A

Kinematics Analysis: Comparison Between the Cruciate Retaining, Fixed Bearing Primary Total Knee Arthroplasty ATTUNE TM Knee System and the Fixed Bearing PFC Sigma Curved Total Knee Arthroplasty

Dr. Renate List1 site in 1 country19 target enrollmentOctober 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Total Knee Anthroplasty
Sponsor
Dr. Renate List
Enrollment
19
Locations
1
Primary Endpoint
Comparison of the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The primary objective is to quantify and compare the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.

The secondary objective is to describe the kinematics in terms of range of motion, patterns of anterior-posterior motion of the nearest medial and lateral points ("posterior femoral rollback") and tibio-femoral internal/external rotation as well as the kinetics during daily activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent by means of video-fluoroscopy.

Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and to the Center for Orthopaedic Engineering of the University of Denver, where it will be used within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and changes in the musculoskeletal system due to the TKA.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
December 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dr. Renate List
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Renate List

Dr. sc. ETH, Group Leader Clinical Movement Biomechanics, Senior Research Associate

Institute for Biomechanics, ETH Zürich

Eligibility Criteria

Inclusion Criteria

  • Unilateral TKA (ATTUNETM/Sigma) due to osteoarthritis
  • Good clinical outcome, KOOS \> 70
  • No or very low pain VAS \< 2
  • At least one year post-op
  • Standardized general health survey score (SF-12) within the normal range for people in their age group

Exclusion Criteria

  • Actual significant problem on lower extremities
  • Misaligned TKA
  • Any other arthroplasty at the lower extremities
  • Patient incapable to understand and sign informed consent
  • Incapable of performing the motion tasks
  • Pregnancy

Outcomes

Primary Outcomes

Comparison of the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA

Time Frame: 3 hours

With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the ATTUNETM System during daily activities and allows a comparison to a conventional TKA based on the same methodology. The knowledge of the in vivo kinematic behaviour of the ATTUNETM System in comparison to the conventional TKA leads to an improved understanding of the design principle.

Study Sites (1)

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