Comprehensive Assessment of the Musculoskeletal System

NCT02156011 | Completed

• 2 other identifiers: EK 2013-N-90EA4/069/06
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Video-fluoroscopy outcome parameters (kinematic parameters):

  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.

  up to 4 weeks

• Knee joint loading outcome parameters (kinetic parameters)

  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.

  up to 4 weeks

Secondary Outcomes (3)

• Optical motion capture outcome parameters

  up to 4 weeks

• Ground reaction force outcome parameters:

  up to 4 weeks

• Electromyography outcome parameters

  up to 4 weeks

Other Outcomes (1)

• Clinical outcome parameters

  already available

Study Arms (1)

Instrumented knee implant

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.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after total knee replacement surgery from the Charité- Universitätsmedizin in Berlin, Germany

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Robert Mathys Stiftung, Bettlach, Switzerland: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Institute for Biomechanics, ETH Zurich

Zurich, 8093, Switzerland

Location

Related Publications (10)

• 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.

  PMID: 19637213 BACKGROUND

• 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.

  PMID: 21764353 BACKGROUND

• 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.

  PMID: 15099644 BACKGROUND

• 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.

  PMID: 22267190 BACKGROUND

• 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.

  PMID: 16473011 BACKGROUND

• 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.

  PMID: 23050714 BACKGROUND

• 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.

  PMID: 23093123 BACKGROUND

• 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.

  PMID: 21569522 BACKGROUND

• 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.

  PMID: 20547061 BACKGROUND

• 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.

  PMID: 16979893 BACKGROUND

Related Links

• Institute of Biomechanics, ETH Zurich, Switzerland (Primary Study Site)
• Free public database from instrumented implants, Charité - Universitätsmedizin Berlin Germany

Study Officials

• William R Taylor, PhD

  Institute for Biomechanics ETH Zurich Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Movement Biomechanics

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 5, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: October 9, 2017
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

CH (1)