Clinical trial NCT03033940: Total Knee Arthroplasty Videofluoroscopy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Anthroplasty
Lead sponsor: Institute for Biomechanics, ETH Zürich
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Institute for Biomechanics, ETH Zurich
Study officials:
References: