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| ID | Type | Description | Link |
|---|---|---|---|
| VR - 2009-6725). | Other Identifier | EPN Linköping M59-06 |
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Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.
The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration.
We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not.
Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.
Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Tourniquet | Other | We compare tourniquet or not in knee surgery |
|
| Tourniquet | Active Comparator | We compare tourniquet or not in knee surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No use of tourniquet | Procedure | Tourniquet is not applied i 25 pts |
|
| Measure | Description | Time Frame |
|---|---|---|
| View protocol record | Measures the migration of the knee prosthesis | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| View Protocol Record | Meassures of total bledding, ROM, KOOS, Pain | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Aspenberg, MD,PhD | Linkoeping University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motala hospital | Motala | Sweden |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D006470 | Hemorrhage |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014111 | Tourniquets |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Tourniquet | Procedure | Use of tourniquet |
|
| D012216 |
| Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |