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The purpose of this study is to measure the effect of fibrin sealant on reducing blood loss, pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on Range Of Movement (ROM) and strength is examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin Sealent | Active Comparator |
| |
| Saline water | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin sealant | Drug | Fibrin sealant is applied on the surfaces of bone and soft tissue of surgery after placement of the prothesis due to the randomised knee. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | 24 hours postopertive blood loss estimated by drains from each of the knees . | 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | 2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secundary outcomes by a physiotherapist. Measurement of postoperative pain is done on the 1st, 2nd and 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department. | 2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Skovgaard Nielsen, M.D | Hvidovre University Hospital | Principal Investigator |
| Henrik Husted, M.D. | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | Denmark |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D000068357 | Saline Waters |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Saline water | Drug | Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo). |
|
| swelling | 2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secundary outcomes by a physiotherapist. Measurement of postoperative swelling is done on the 1st, 2nd and 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department. The swelling is measured as the difference of circumference 1 cm proximal of the patella 2-3 weeks before surgery and at the outlined postoperative times. | 2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day |
| Range of Movement (ROM) | 2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secondary outcomes by a physiotherapist. Measurement of postoperative ROM is done on the 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department. | 2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day |
| Strength | 2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secondary outcomes by a physiotherapist. Measurement of postoperative strength is done on the 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department. | 2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D004777 |
| Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |