ArthroplastyNCT02828293
Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
An observational study of Arthroplasty and Replacement, Knee, run by Medacta International SA at 2 sites 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 and the GMK UC Fixed Bearing TKA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Dynamic videofluoroscopic analysis
- How many people
- 30 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Sep 2014to Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 8-10 subjects with Medacta GMK Sphere TKA, 8-10 subjects with GMK PS Fixed Bearing TKA and 8-10 subjects with a GMK UC Fixed Bearing TKA will be involved in this project. The subject recruitment will be based on the clinical reports of the follow-up examination including the standard clinical assessed parameters alignment, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the visual analog scale (VAS)
Who may be able to join
- subjects bearing a TKA with one of the studied prosthesis
- male and female older than 18 years old
- patients who are willing and able to sign an informed consent form
Who cannot join
- any case not described in the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
Institute for Biomechanics ETH Zurich
Zurich, CH-8092
Renate List, rlist@ethz.ch
- Recruiting
Institute for Biomechanics ETH Zurich
Zurich, CH-8092
William Taylor, +41 44 632 2354
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 and the GMK UC Fixed Bearing TKA.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Dynamic videofluoroscopic analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic videofluoroscopic analysisOther
Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| GMK Sphere | Patients who underwent total knee replacement using GMK Sphere implants. Patients underwent surgery before the inclusion in the study. Receives: Other: Dynamic videofluoroscopic analysis | |
| GMK PS Fixed Bearing | Patients who underwent total knee replacement using GMK PS Fixed Bearing implants. Patients underwent surgery before the inclusion in the study. Receives: Other: Dynamic videofluoroscopic analysis | |
| GMK UC Fixed Bearing | Patients who underwent total knee replacement using GMK UC Fixed Bearing implants. Patients underwent surgery before the inclusion in the study. Receives: Other: Dynamic videofluoroscopic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
2D/3D videofluoroscopy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by Medacta International SAThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828293
- Sponsor's protocol ID
- P02.014.11
- Status last verified
- Sep 2017
- First submitted
- 1 Jul 2016
- Last updated
- 6 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. 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
- NCT02828293
- Acronym / sponsor ID
- P02.014.11
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 11 Jul 2016 (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 and the GMK UC Fixed Bearing TKA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GMK Sphere | – | Other: Dynamic videofluoroscopic analysisPatients who underwent total knee replacement using GMK Sphere implants. Patients underwent surgery before the inclusion in the study. |
| GMK PS Fixed Bearing | – | Other: Dynamic videofluoroscopic analysisPatients who underwent total knee replacement using GMK PS Fixed Bearing implants. Patients underwent surgery before the inclusion in the study. |
| GMK UC Fixed Bearing | – | Other: Dynamic videofluoroscopic analysisPatients who underwent total knee replacement using GMK UC Fixed Bearing implants. Patients underwent surgery before the inclusion in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 8-10 subjects with Medacta GMK Sphere TKA, 8-10 subjects with GMK PS Fixed Bearing TKA and 8-10 subjects with a GMK UC Fixed Bearing TKA will be involved in this project. The subject recruitment will be based on the clinical reports of the follow-up examination including the standard clinical assessed parameters alignment, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the visual analog scale (VAS)
Key inclusion criteria (3 listed)
- subjects bearing a TKA with one of the studied prosthesis
- male and female older than 18 years old
- patients who are willing and able to sign an informed consent form
Key exclusion criteria (1 listed)
- any case not described in the inclusion criteria
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 |
|---|---|---|
| Dynamic videofluoroscopic analysisPatients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy. | Other | GMK PS Fixed Bearing, GMK Sphere, GMK UC Fixed Bearing |
Primary outcome
2D/3D videofluoroscopy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty and Replacement, Knee, run by Medacta International SA at 2 sites 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2D/3D videofluoroscopy (time frame: 1 year). 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 6 Mar 2019.