Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
19 participants
OBSERVATIONAL
2016-10-31
2018-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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ATTUNE TM subjects
Observational use of fluoroscopy
PFC Sigma subjects
Observational use of fluoroscopy
Interventions
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Observational use of fluoroscopy
Eligibility Criteria
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Inclusion Criteria
* 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
* Misaligned TKA
* Any other arthroplasty at the lower extremities
* Patient incapable to understand and sign informed consent
* Incapable of performing the motion tasks
* Pregnancy
18 Years
ALL
Yes
Sponsors
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Dr. Renate List
OTHER
Responsible Party
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Dr. Renate List
Dr. sc. ETH, Group Leader Clinical Movement Biomechanics, Senior Research Associate
Locations
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Institute for Biomechanics, ETH Zurich
Zurich, , Switzerland
Countries
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Other Identifiers
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ATTUNE-SIGMA-2016
Identifier Type: -
Identifier Source: org_study_id