Total Knee Arthroplasty Videofluoroscopy

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.

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Key information

Conditions

Total Knee Anthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Biomechanics, ETH Zurich

Zurich, 8093, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Observational use of fluoroscopy

Radiation

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.

Sponsors and collaborators

Lead sponsor

Dr. Renate List

Other

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jan 27, 2017
Registry last updated: Dec 20, 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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