Total Knee ArthroplastyNCT03041857
Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
An observational study of Total Knee Arthroplasty and Tibiofemoral Kinematics, run by Dr. Renate List at 1 site in Switzerland.
Trial summary
The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and downhill walking by means of videofluoroscopy. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Total Knee Arthroplasty, Tibiofemoral Kinematics
- What is being tested?
- Observational use of fluoroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2013to Sep 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants fulfilling all of the following inclusion criteria are eligible for the study. The presence of any one of the following exclusion criteria will lead to the exclusion of the participant.
Who may be able to join
- Female or male
- Age: 40 to 100 years
- Unilateral TKA
- ≥ 1 years postoperatively
- BMI ≤ 33
- Good outcome, WOMAC between 0 to 28 (0-14 (Excellent), 15-28 (Good)) No pain subjects, VAS ≤ 2
- Good health condition, adequate for test procedure
Who cannot join
- Other actual significant problem on lower extremities
- Any other arthroplasty at the lower extremities
- Subject incapable to understand and sign informed consent
- Pregnancy at time of testing
- Incapable of performing the motion tasks
- Misaligned TKA (≥ ± 3° from mechanical axis)
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and downhill walking by means of videofluoroscopy.
Read the detailed description
Total arthroplasty of the knee (TKA) aims to relieve patient pain and improve functionality of the joint. To maintain sufficient range of motion, but also not overload the surrounding soft tissue structures, reproduction of tibio-femoral kinematics of the healthy knee is thought to be beneficial. In previous studies, it has been shown that the medial condyle, described by the centre of the medial condylar sphere, does not move anterioposteriorly during progressing joint flexion, whereas the lateral condyle has been observed to translate in a posterior direction producing tibial internal rotation with flexion (Freeman and Pinskerova 2003, Pinskerova, Johal et al. 2004, Freeman and Pinskerova 2005). The GMK Sphere prosthesis is specifically designed to mimic the healthy kinematics with providing a medial pivot.
The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Fixed Bearing. The study includes the simultaneous assessment of the 3D kinematics of the TKA by means of an automated moving fluoroscope and subsequent 2D/3D registration based on CAD models of the TKA, whole leg kinematics by means of skin markers and ground reaction forces during level walking, stair descent and downhill walking a 10° inclined slope. Precisely, the aim is to assess tibio-femoral kinematics in 8-10 TKA subjects implanted one or more years previously with the GMK Sphere prosthesis. In addition, 8-10 conventional GMK PS Fixed Bearing TKA subjects, as well as 8-10 GMK UC Mobile Bearing TKA subjects will be measured to provide a comparison against the GMK Sphere prosthesis kinematics.
- Conditions
- Total Knee Arthroplasty, Tibiofemoral Kinematics
- Being tested
- Observational use of fluoroscopy
- Keywords
- Videofluoroscopy, GMK Sphere, GMK PS Fixed Bearing, GMK UC Mobile Bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational use of fluoroscopyRadiation
| Study group | Role | What they receive |
|---|---|---|
| GMK Sphere | Subjects with a unilateral Medacta GMK Sphere TKA Receives: Radiation: Observational use of fluoroscopy | |
| GMK PS | Subjects with a unilateral Medacta GMK Primary PS Fixed Bearing TKA Receives: Radiation: Observational use of fluoroscopy | |
| GMK UC | Subjects with a unilateral Medacta GMK Primary UC Fixed Bearing TKA Receives: Radiation: Observational use of fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the three-dimensional kinematics of the GMK Sphere Fixed Bearing TKA to the kinematics of the GMK Primary PS fixed bearing and GMK Primary UC Mobile Bearing TKA.
With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, downhill walking and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the GMK Sphere System during daily activities. The knowledge of the in vivo kinematic behaviour of the GMK Sphere System compared to conventional GMK PS Fixed Bearing and GMK UC Mobile Bearing TKA leads to an improved understanding of the design principle. Observation of the kinematics in terms of range of motion, patterns of anterior-posterior motion of medial and lateral condyle points ("posterior femoral rollback") and tibio-femoral internal/external rotation.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startDec 2013
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Renate List
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Winterthur KSW, Balgrist University Hospital
- Responsible party
- Sponsor-investigator, Dr. Renate List, Institute for Biomechanics, ETH Zürich
- Investigators
- Renate List, Dr., Principal investigator, Institute for Biomechanics, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041857
- Sponsor's protocol ID
- MedactaGMKSphere
- Status last verified
- Sep 2017
- First submitted
- 4 Mar 2016
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
- ClinicalTrials.gov ID
- NCT03041857
- Acronym / sponsor ID
- MedactaGMKSphere
- Conditions
- Total Knee Arthroplasty, Tibiofemoral Kinematics
- Keywords
- Videofluoroscopy, GMK Sphere, GMK PS Fixed Bearing, GMK UC Mobile Bearing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Renate ListUniversity, hospital or other
- Collaborators
- Kantonsspital Winterthur KSW, Balgrist University Hospital
- Study start
- Dec 2013 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 3 Feb 2017 (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 project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and downhill walking by means of videofluoroscopy.
Detailed description
Total arthroplasty of the knee (TKA) aims to relieve patient pain and improve functionality of the joint. To maintain sufficient range of motion, but also not overload the surrounding soft tissue structures, reproduction of tibio-femoral kinematics of the healthy knee is thought to be beneficial. In previous studies, it has been shown that the medial condyle, described by the centre of the medial condylar sphere, does not move anterioposteriorly during progressing joint flexion, whereas the lateral condyle has been observed to translate in a posterior direction producing tibial internal rotation with flexion (Freeman and Pinskerova 2003, Pinskerova, Johal et al. 2004, Freeman and Pinskerova 2005). The GMK Sphere prosthesis is specifically designed to mimic the healthy kinematics with providing a medial pivot.
The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Fixed Bearing. The study includes the simultaneous assessment of the 3D kinematics of the TKA by means of an automated moving fluoroscope and subsequent 2D/3D registration based on CAD models of the TKA, whole leg kinematics by means of skin markers and ground reaction forces during level walking, stair descent and downhill walking a 10° inclined slope. Precisely, the aim is to assess tibio-femoral kinematics in 8-10 TKA subjects implanted one or more years previously with the GMK Sphere prosthesis. In addition, 8-10 conventional GMK PS Fixed Bearing TKA subjects, as well as 8-10 GMK UC Mobile Bearing TKA subjects will be measured to provide a comparison against the GMK Sphere prosthesis kinematics.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GMK Sphere | – | Radiation: Observational use of fluoroscopySubjects with a unilateral Medacta GMK Sphere TKA |
| GMK PS | – | Radiation: Observational use of fluoroscopySubjects with a unilateral Medacta GMK Primary PS Fixed Bearing TKA |
| GMK UC | – | Radiation: Observational use of fluoroscopySubjects with a unilateral Medacta GMK Primary UC Fixed Bearing TKA |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants fulfilling all of the following inclusion criteria are eligible for the study. The presence of any one of the following exclusion criteria will lead to the exclusion of the participant.
Key inclusion criteria (7 listed)
- Female or male
- Age: 40 to 100 years
- Unilateral TKA
- ≥ 1 years postoperatively
- BMI ≤ 33
Key exclusion criteria (6 listed)
- Other actual significant problem on lower extremities
- Any other arthroplasty at the lower extremities
- Subject incapable to understand and sign informed consent
- Pregnancy at time of testing
- Incapable of performing the motion tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational use of fluoroscopy | Radiation | GMK PS, GMK Sphere, GMK UC |
Primary outcome
Comparison of the three-dimensional kinematics of the GMK Sphere Fixed Bearing TKA to the kinematics of the GMK Primary PS fixed bearing and GMK Primary UC Mobile Bearing TKA.
Time frame: 3 hours
With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, downhill walking and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the GMK Sphere System during daily activities. The knowledge of the in vivo kinematic behaviour of the GMK Sphere System compared to conventional GMK PS Fixed Bearing and GMK UC Mobile Bearing TKA leads to an improved understanding of the design principle. Observation of the kinematics in terms of range of motion, patterns of anterior-posterior motion of medial and lateral condyle points ("posterior femoral rollback") and tibio-femoral internal/external rotation.
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 29 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Renate List, Dr. principal investigator
Institute for Biomechanics, ETH Zurich
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 and Tibiofemoral Kinematics, run by Dr. Renate List 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 7 inclusion and 6 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 29 Sep 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?
Comparison of the three-dimensional kinematics of the GMK Sphere Fixed Bearing TKA to the kinematics of the GMK Primary PS fixed bearing and GMK Primary UC Mobile Bearing TKA. (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2017.