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Total Knee Arthroplasty Videofluoroscopy

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ClinicalTrials.gov Identifier: NCT03033940
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Renate List, Institute for Biomechanics, ETH Zürich

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.


Condition or disease Intervention/treatment
Total Knee Anthroplasty Radiation: Observational use of fluoroscopy

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: 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
Actual Study Start Date : October 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Group/Cohort Intervention/treatment
ATTUNE TM subjects Radiation: Observational use of fluoroscopy
PFC Sigma subjects Radiation: Observational use of fluoroscopy



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is a prospective, observational study on 15 subjects with the ATTUNE TM CR Fixed Bearing TKA and 15 subjects with PFC Sigma Curved CR Fixed Bearing TKA during level walking, deep knee bend (only ATTUNE TM subjects), sitting down onto a chair, standing up from a chair and stair descent. The present study extends the subject groups of a previous feasibility study (KEK-ZH-Nr. 2014-0468) from 5 to 15 ATTUNE TM and from 6 to 15 PFC Sigma Curved CR Fixed Bearing TKA subjects. Based on a power analysis of the existing data of 5 ATTUNE TM subjects and 6 subjects with a PFC Sigma Curved CR Fixed Bearing TKA in the previous feasibility study (KEK-ZH-Nr. 2014-0468) the minimal sample size for the comparative evaluation of 15 subjects within each group was estimated. The participants must be able to perform the daily activity tasks mentioned above
Criteria

Inclusion Criteria:

  • Unilateral TKA (ATTUNETM/Sigma) due to osteoarthritis
  • BMI ≤ 33
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033940


Locations
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Switzerland
Institute for Biomechanics, ETH Zurich
Zurich, Switzerland, 8093
Sponsors and Collaborators
Dr. Renate List
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Responsible Party: Dr. Renate List, Dr. sc. ETH, Group Leader Clinical Movement Biomechanics, Senior Research Associate, Institute for Biomechanics, ETH Zürich
ClinicalTrials.gov Identifier: NCT03033940    
Other Study ID Numbers: ATTUNE-SIGMA-2016
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019