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Medacta GMK PS is not in use anymore
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GMK Sphere | Other | Patients receiving total knee replacement surgery with the device "Medacta GMK Sphere" |
|
| GMK PS | Other | Patients receiving total knee replacement surgery with the device "Medacta GMK PS" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee endoprothesis | Device | Total knee endoprosthesis after knee joint osteoarthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee injury and Osteoarthritis Outcome Score | Knee injury and Osteoarthritis Outcome Score: 100 = maximum score, 0 = minimum score | preoperative, 1 year, 5 year and 10 year after surgery |
| Change in Forgotten Joint Score | Forgotten Joint Score: 100 = maximum score, 0 = minimum score | 1 year, 5 year and 10 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in revison | Revision rate comparision with the baseline at 1 year | 1 year, 5 year and 10 year after surgery |
| Change in range of motion | Range of motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Koch, PD Dr. med. | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Winterthur | Winterthur | Canton of Zurich | 8400 | Switzerland |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| preoperative, 1 year, 5 year and 10 year after surgery |
| D012216 |
| Rheumatic Diseases |