Clinical trial NCT02156011: Comprehensive Assessment of the Musculoskeletal System
Official title: Kinematics and Joint Loading in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthroplasty
Keywords: In vivo knee joint kinematics
In vivo knee joint loading
Video-fluoroscopy
Instrumented implants
Optical motion capture
Ground reaction forces
Electromyography
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Robert Mathys Stiftung, Bettlach, Switzerland
name: Charite University, Berlin, Germany
First posted: 2014-06-05
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after total knee replacement surgery from the Charité- Universitätsmedizin in Berlin, Germany

Brief summary: 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.

Detailed description: 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:

* One legged standing and lifting the heel to stand on tiptoe.
* Extension of the knee joint against a load by means of a strap around the lower leg just above the ankle. (Subject is sitting on a bench, lower legs are hanging down).
* Flexion of the knee joint against a load by means of a strap around the lower leg just above the ankle. (Subject is sitting on a bench, lower legs are hanging down).
* Dorsiflexion of the ankle against a manual resistant force of the investigator. (Subject is sitting on a bench, lower legs are hanging down).

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:

* Standing trial in an anatomic upright position
* Calibration motion (Standing in upright position, followed by free movement of legs and arms)
* Four basic motion tasks to define functional estimated joint axis, respectively centers: dorsiplantarflexion motion of the ankle, inversion/eversion motion of the ankle, flexion/extension motion of the knee, hip circumduction (List et al., 2012b)

Static trials:

* Standing trial in an anatomic upright position captured from the side.
* Standing trial in an anatomic upright position captured from an angle of 45°.

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.

* Level gait
* Stair descent a two steps staircase
* Downhill walking a 10° inclined slope
* Sit down and stand up from a chair
* Squatting

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.

Eligibility criteria: Inclusion Criteria:

* Instrumented TKA
* Participant of the study EA4/069/06, Charité- Universitätsmedizin Berlin, Germany,

Exclusion Criteria:

* Not able to walk freely without walking aid
* Any medical condition that could impact on study results

Primary outcomes:
measure: Video-fluoroscopy outcome parameters (kinematic parameters):
timeFrame: up to 4 weeks
measure: Knee joint loading outcome parameters (kinetic parameters)
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Optical motion capture outcome parameters
timeFrame: up to 4 weeks
measure: Ground reaction force outcome parameters:
timeFrame: up to 4 weeks
measure: Electromyography outcome parameters
timeFrame: up to 4 weeks
Other outcomes:
measure: Clinical outcome parameters
timeFrame: already available
Locations:
city: Zurich
country: Switzerland
facility: Institute for Biomechanics, ETH Zurich
Study officials:
affiliation: Institute for Biomechanics ETH Zurich Switzerland
name: William R Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Konig C, Sharenkov A, Matziolis G, Taylor WR, Perka C, Duda GN, Heller MO. Joint line elevation in revision TKA leads to increased patellofemoral contact forces. J Orthop Res. 2010 Jan;28(1):1-5. doi: 10.1002/jor.20952.
citation: Konig C, Matziolis G, Sharenkov A, Taylor WR, Perka C, Duda GN, Heller MO. Collateral ligament length change patterns after joint line elevation may not explain midflexion instability following TKA. Med Eng Phys. 2011 Dec;33(10):1303-8. doi: 10.1016/j.medengphy.2011.06.008. Epub 2011 Jul 20.
citation: Taylor WR, Heller MO, Bergmann G, Duda GN. Tibio-femoral loading during human gait and stair climbing. J Orthop Res. 2004 May;22(3):625-32. doi: 10.1016/j.orthres.2003.09.003.
citation: Trepczynski A, Kutzner I, Kornaropoulos E, Taylor WR, Duda GN, Bergmann G, Heller MO. Patellofemoral joint contact forces during activities with high knee flexion. J Orthop Res. 2012 Mar;30(3):408-15. doi: 10.1002/jor.21540. Epub 2011 Aug 30.
citation: Zihlmann MS, Gerber H, Stacoff A, Burckhardt K, Szekely G, Stussi E. Three-dimensional kinematics and kinetics of total knee arthroplasty during level walking using single plane video-fluoroscopy and force plates: a pilot study. Gait Posture. 2006 Dec;24(4):475-81. doi: 10.1016/j.gaitpost.2005.12.012. Epub 2006 Feb 10.
citation: List R, Foresti M, Gerber H, Goldhahn J, Rippstein P, Stussi E. Three-dimensional kinematics of an unconstrained ankle arthroplasty: a preliminary in vivo videofluoroscopic feasibility study. Foot Ankle Int. 2012 Oct;33(10):883-92. doi: 10.3113/FAI.2012.0883.
citation: List R, Gerber H, Foresti M, Rippstein P, Goldhahn J. A functional outcome study comparing total ankle arthroplasty (TAA) subjects with pain to subjects with absent level of pain by means of videofluoroscopy. Foot Ankle Surg. 2012 Dec;18(4):270-6. doi: 10.1016/j.fas.2012.04.001. Epub 2012 May 12.
citation: Heller MO, Mehta M, Taylor WR, Kim DY, Speirs A, Duda GN, Perka C. Influence of prosthesis design and implantation technique on implant stresses after cementless revision THR. J Orthop Surg Res. 2011 May 13;6:20. doi: 10.1186/1749-799X-6-20.
citation: Taylor WR, Kornaropoulos EI, Duda GN, Kratzenstein S, Ehrig RM, Arampatzis A, Heller MO. Repeatability and reproducibility of OSSCA, a functional approach for assessing the kinematics of the lower limb. Gait Posture. 2010 Jun;32(2):231-6. doi: 10.1016/j.gaitpost.2010.05.005. Epub 2010 May 23.
citation: Stacoff A, Kramers-de Quervain IA, Luder G, List R, Stussi E. Ground reaction forces on stairs. Part II: knee implant patients versus normals. Gait Posture. 2007 Jun;26(1):48-58. doi: 10.1016/j.gaitpost.2006.07.015. Epub 2006 Sep 18.