Knee OsteoarthritisNCT03896451
Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
A study testing Total knee endoprothesis in people with Knee Osteoarthritis, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
The purpose of the study is to compare the clinical outcome after two total knee endoprosthesis designs Medacta GMK Sphere and Medacta GMK PS. Primary outcome measures KOOS, Forgotten Knee Score and range of motion. Single-center, randomized trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Total knee endoprothesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Feb 2019to 31 Mar 2031
- Phase
- Interventional
- 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
Who may be able to join
- patient is eligible for a total knee replacement
- patient is eligible for a Medacta GMK Sphere or Medacta GMK PS knee prosthesis
- patient signed the informed consent
Who cannot join
- patient is pregnant
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8400
About this study
Official title: Prospactive Randomized Monocentric Comparison Study Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
The purpose of the study is to compare the clinical outcome after two total knee endoprosthesis designs Medacta GMK Sphere and Medacta GMK PS.
Primary outcome measures KOOS, Forgotten Knee Score and range of motion.
Single-center, randomized trial
Read the detailed description
The clinical outcome measures were measured preoperativ and postoperativ (1 year, 5 year and 10 year).
Secondary outcome measures: number of reoperations and revisions, survival of the prosthesis
The patient population would consist patients with knee osteoarthritis eligible for total knee replacement
The aim of the study is to evaluate the effect of the knee prosthesis design on the patient outcome
- Conditions
- Knee Osteoarthritis
- Being tested
- Total knee endoprothesis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee endoprothesisDevice
Total knee endoprosthesis after knee joint osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| GMK Sphere | Other | Patients receiving total knee replacement surgery with the device "Medacta GMK Sphere" Receives: Device: Total knee endoprothesis |
| GMK PS | Other | Patients receiving total knee replacement surgery with the device "Medacta GMK PS" Receives: Device: Total knee endoprothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee injury and Osteoarthritis Outcome Score
Knee injury and Osteoarthritis Outcome Score: 100 = maximum score, 0 = minimum score
Measured: preoperative, 1 year, 5 year and 10 year after surgery
Change in Forgotten Joint Score
Forgotten Joint Score: 100 = maximum score, 0 = minimum score
Measured: 1 year, 5 year and 10 year after surgery
Secondary outcomes (2)
Change in revison
Revision rate comparision with the baseline at 1 year
Measured: 1 year, 5 year and 10 year after surgery
Change in range of motion
Range of motion
Measured: preoperative, 1 year, 5 year and 10 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start2 Feb 2019
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Why it stopped: Medacta GMK PS is not in use anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Koch, Kantonsspital Winterthur KSW
- Investigators
- Peter Koch, PD Dr. med., Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896451
- Sponsor's protocol ID
- PS vs. Sphere
- Status last verified
- Sep 2020
- First submitted
- 26 Mar 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospactive Randomized Monocentric Comparison Study Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
- ClinicalTrials.gov ID
- NCT03896451
- Acronym / sponsor ID
- PS vs. Sphere
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Medacta GMK PS is not in use anymore
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 1 Apr 2019 (actual)
- 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 purpose of the study is to compare the clinical outcome after two total knee endoprosthesis designs Medacta GMK Sphere and Medacta GMK PS.
Primary outcome measures KOOS, Forgotten Knee Score and range of motion.
Single-center, randomized trial
Detailed description
The clinical outcome measures were measured preoperativ and postoperativ (1 year, 5 year and 10 year).
Secondary outcome measures: number of reoperations and revisions, survival of the prosthesis
The patient population would consist patients with knee osteoarthritis eligible for total knee replacement
The aim of the study is to evaluate the effect of the knee prosthesis design on the patient outcome
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GMK Sphere | Other | Device: Total knee endoprothesisPatients receiving total knee replacement surgery with the device "Medacta GMK Sphere" |
| GMK PS | Other | Device: Total knee endoprothesisPatients receiving total knee replacement surgery with the device "Medacta GMK PS" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient is eligible for a total knee replacement
- patient is eligible for a Medacta GMK Sphere or Medacta GMK PS knee prosthesis
- patient signed the informed consent
Key exclusion criteria (1 listed)
- patient is pregnant
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 |
|---|---|---|
| Total knee endoprothesisTotal knee endoprosthesis after knee joint osteoarthritis | Device | GMK PS, GMK Sphere |
Primary outcome
Change in Knee injury and Osteoarthritis Outcome Score
Time frame: preoperative, 1 year, 5 year and 10 year after surgery
Knee injury and Osteoarthritis Outcome Score: 100 = maximum score, 0 = minimum score
Change in Forgotten Joint Score
Time frame: 1 year, 5 year and 10 year after surgery
Forgotten Joint Score: 100 = maximum score, 0 = minimum score
2 secondary outcomes
Change in revison
Time frame: 1 year, 5 year and 10 year after surgery
Change in range of motion
Time frame: preoperative, 1 year, 5 year and 10 year after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- 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.
Peter Koch, PD Dr. med. principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee endoprothesis in people with Knee Osteoarthritis, run by Kantonsspital Winterthur KSW 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 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: withdrawn, as of the sponsor's last update on 9 Sep 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Knee injury and Osteoarthritis Outcome Score (time frame: preoperative, 1 year, 5 year and 10 year after surgery). 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?
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 9 Sep 2020.