Knee Osteoarthritis
Conditions
Brief 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
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
Interventions
DEVICETotal knee endoprothesis
Total knee endoprosthesis after knee joint osteoarthritis
Sponsors
Kantonsspital Winterthur KSW
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* patient is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee injury and Osteoarthritis Outcome Score | 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 | 1 year, 5 year and 10 year after surgery | Forgotten Joint Score: 100 = maximum score, 0 = minimum score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in revison | 1 year, 5 year and 10 year after surgery | Revision rate comparision with the baseline at 1 year |
| Change in range of motion | preoperative, 1 year, 5 year and 10 year after surgery | Range of motion |
Countries
Switzerland
Outcome results
None listed