Total Knee ArthroplastyCAMS-KneeNCT02156011
Comprehensive Assessment of the Musculoskeletal System
An observational study of Total Knee Arthroplasty, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2014to 9 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after total knee replacement surgery from the Charité- Universitätsmedizin in Berlin, Germany
Who may be able to join
- Instrumented TKA
- Participant of the study EA4/069/06, Charité- Universitätsmedizin Berlin, Germany,
Who cannot join
- Not able to walk freely without walking aid
- Any medical condition that could impact on study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinematics and Joint Loading in Total Knee Arthroplasty
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.
Read the 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 4 weeks
Secondary outcomes (3)
Optical motion capture outcome parameters
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.
Measured: up to 4 weeks
Ground reaction force outcome parameters:
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
Measured: up to 4 weeks
Electromyography outcome parameters
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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Mathys Stiftung, Bettlach, Switzerland, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, William R. Taylor, Swiss Federal Institute of Technology
- Investigators
- William R Taylor, PhD, Principal investigator, Institute for Biomechanics ETH Zurich Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156011
- Sponsor's protocol ID
- EK 2013-N-90
- Other IDs
- EA4/069/06
- Acronym
- CAMS-Knee
- Status last verified
- Oct 2017
- First submitted
- 2 Jun 2014
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19637213Konig 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.
PubMed 21764353Taylor 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.
PubMed 15099644Trepczynski 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.
PubMed 22267190Zihlmann 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.
PubMed 16473011List 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.
PubMed 23050714List 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.
PubMed 23093123Heller 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.
PubMed 21569522Taylor 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.
PubMed 20547061Stacoff 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.
PubMed 16979893
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematics and Joint Loading in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02156011
- Acronym / sponsor ID
- CAMS-Knee / EK 2013-N-90
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Robert Mathys Stiftung, Bettlach, Switzerland, Charite University, Berlin, Germany
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after total knee replacement surgery from the Charité- Universitätsmedizin in Berlin, Germany
Key inclusion criteria (2 listed)
- Instrumented TKA
- Participant of the study EA4/069/06, Charité- Universitätsmedizin Berlin, Germany,
Key exclusion criteria (2 listed)
- Not able to walk freely without walking aid
- Any medical condition that could impact on study results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Video-fluoroscopy outcome parameters (kinematic parameters):
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.
Knee joint loading outcome parameters (kinetic parameters)
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.
3 secondary outcomes
Optical motion capture outcome parameters
Time frame: up to 4 weeks
Ground reaction force outcome parameters:
Time frame: up to 4 weeks
Electromyography outcome parameters
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Background: PubMed 19637213Konig 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.
- Background: PubMed 21764353Konig 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.
- Background: PubMed 15099644Taylor 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.
- Background: PubMed 22267190Trepczynski 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.
- Background: PubMed 16473011Zihlmann 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.
- Background: PubMed 23050714List 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.
- Background: PubMed 23093123List 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.
- Background: PubMed 21569522Heller 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.
- Background: PubMed 20547061Taylor 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.
- Background: PubMed 16979893Stacoff 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.
- Institute of Biomechanics, ETH Zurich, Switzerland (Primary Study Site)Link provided by the sponsor.
- Free public database from instrumented implants, Charité - Universitätsmedizin Berlin GermanyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William R Taylor, PhD principal investigator
Institute for Biomechanics ETH Zurich Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video-fluoroscopy outcome parameters (kinematic parameters): (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156011, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.