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| Name | Class |
|---|---|
| Regionshospitalet Silkeborg | OTHER |
| Gigtforeningen | OTHER |
| Protesekompagniet | UNKNOWN |
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The purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs.
The patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. This design difference might in principle enable the patients in the latter group to rehabilitate towards a more normal gait pattern.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed bearing | Active Comparator | One of the 2 used implants. |
|
| Rotating platform | Active Comparator | One of the 2 used implants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P.F.C. Sigma knee arthroplasty | Device | Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radio Stereometric Analysis | Patients are analysed with stereo x-rays to asses implant micromigration. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gait analysis | Motion analysis is performed prior to surgery and after 6 and 12 months follow-up. Patients serve as their own control. | 12 months |
| DXA | Dual Energy X-ray Absorptiometry (DXA) is used to asses bone mineral density (BMD) around the implant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kjeld Soballe, DMsc | Aarhus Sygehus THG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silkeborg Regional Hospital | Silkeborg | 8600 | Denmark |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 24 months |