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| Name | Class |
|---|---|
| Regional Hospital Holstebro | OTHER |
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This double-blinded randomized control study will use kinematic and kinetic measures to compare an anatomical congruent prosthetic knee design to a standard prosthetic knee design. The patients will be measured pre- and post-operative and compared to a healthy non-osteoarthritis control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cruciate Retaining | Active Comparator |
| |
| Medial Congruent | Active Comparator |
| |
| Healthy Controls | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cruciate Retaining | Device | Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kinematics - knee joint movement | Relative movement (position in millimetres and orientation in degrees) of the knee joint. | 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Articular joint contact | Contact between femur and tibia | 1 year follow-up |
| Kinetic - knee joint contact force | Internal knee forces (normal and share) of the femur and tibia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maiken T Stilling, maiken.stilling@clin.au.dk | University clinic for hand, hip and knee surgery, Regional Hospital Holstebro, Aarhus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic of Hand, Hip and Knee Surgery, Regional Hospital Holstebro | Holstebro | 7500 | Denmark |
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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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| Medial Congruent | Device | Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert. |
|
|
| 1 year follow-up |
| Implant inducible micromotion | Quantifying dynamic inducible micromotion during daily activities. | 1 year follow-up |
| Static implant migration | baseline, three month after surgery and one year after surgery. | 3, 12 and 24 month post operation using first operative day as baseline. |
| Patient Reported Output Measure | Measured pre- and post operation | 1 year follow-up |
| D012216 |
| Rheumatic Diseases |