Institute for Biomechanics, ETH Zurich
Zurich, 8093, Switzerland
NCT Number: NCT02156011
The objective of this research is to synchronously assess in vivo loading data of the knee joint, tibio-femoral 3D kinematics by means of automated video-fluoroscopy, whole leg kinematics by means of skin markers, ground reaction forces, as well as muscle activity patterns in 4 to 6 subjects with instrumented total knee arthroplasty (TKA) during dynamic functional activities of daily life. The comprehensive in vivo dataset will provide unique information to evaluate the relationship between the kinematics, respectively the alignment of the TKA, and the resulting loading of the implant in vivo.
The whole data package will be made available for download on a public database, such that it can be utilized for the testing and improvement of TKA designs as well as for the validation and improvement of musculoskeletal modelling by researchers around the world.
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Notify Me50 year–80 year
All sexes
Observational
Zurich, 8093, Switzerland
STUDY SUBJECTS:
4-6 subjects with an instrumented TKA, that has been implanted within the study "Kniemessprothese: Belastungsmessung bei Patienten mittels einer instrumentierten Knie-Endoprothese" (EA4/069/06) approved and conducted at the Charité- Universitätsmedizin in Berlin, Germany, will be involved in this project. This instrumented prosthesis was implanted in 9 subjects with osteoarthritis.
DATA ACQUISITION:
The testing will be performed at the Institute for Biomechanics at the ETH Zurich. The kinematic and kinetic measurements include video-fluoroscopic tibio-femoral 3D implant motion; whole leg motion capture based on skin markers as well as ground reaction forces. Simultaneously the joint loading is assessed by means of the instrumented TKA and a telemetry unit for transmitting the strain gage signals. In all subjects, muscle activity is additionally simultaneously assessed using surface electromyography (EMG). The electrodes are placed onto the skin at the sites of eight muscles in the lower limbs. At the beginning of the test session, the maximal voluntary contraction will be assessed by means of the EMG electrodes, performing the following four motion tasks:
To familiarize the subjects with the dynamic data acquisition protocol, six test trials will be conducted that just include the motion capture system (motion capture trials, each performed twice). This is followed by the main test procedure, which will consist of two static (static trials) and three dynamic trials (dynamic trials) assessed simultaneously by the video-fluoroscopy, the motion capture systems the force plates, as well as the instrumented TKA. During the dynamic trials the fluoroscopic measurement unit mounted on an automated trolley will move along the subject and capture the motion of the knee in question.
Motion capture trials:
Static trials:
Dynamic trials:
For each of the following activities the subjects has to perform five valid gait cycles or repetitions respectively. A trial is considered valid, when the knee is in the field of view of the image intensifier during the whole cycle and the force plate got hit for level gait, walking downhill and stair descent.
For documentation, all dynamic trials will additionally be captured by two video cameras. All anonymized data will be made available for download on a public database.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 4 weeks
Quantification of the 3D kinematics of the TKA knee through fitting subject-specific 3D computer aided design models to the video-fluoroscopic data during functional activities.
Time frame: up to 4 weeks
In vivo measurements of internal joint contact forces and moments through the use of instrumented implants that are capable of non-invasively transmitting the forces and moments measured within the joint.
Time frame: up to 4 weeks
By means of optical motion capture with passive reflective skin markers, the 3D motion patterns of the entire ipsi- as well as contralateral lower limbs is assessed. This allows the identification of left-right asymmetries and compensation motion in adjacent joints and/or joints of the contralateral leg.
Time frame: up to 4 weeks
The simultaneous measurements of ground reaction forces during dynamic activities allows the assessment of time/distance gait parameters as well as the identification of limping in individual patients
Time frame: up to 4 weeks
In all subjects muscle activity during functional activity is additionally simultaneously assessed using surface electromyography (EMG). The electrodes are placed onto the skin at the sites of eight muscles in the lower limbs.
Time frame: already available
Swiss Federal Institute of Technology
Other
Kinematics and Joint Loading in Total Knee Arthroplasty
Acronym: CAMS-Knee
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