Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty With Focus on Blood Loss, Pain, Swelling and Strength

Study Overview
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Brief Summary
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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.

Official Title
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Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty. A Prospective Randomised Double-blinded Study Focus in on: Blood Loss, Pain, ROM, Swelling and Strength

Conditions
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Blood Loss

Intervention / Treatment
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* Drug: Fibrin sealant
* Drug: Saline water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective bilateral knee arthroplasty Must speak and understand Danish Musk be able to gave oral and written consent. Females must be post-menopausal, and last menstruation must be minimum of one year ago. Exclusion Criteria: Alcohol or medicine abuse Treatment with opioids Allergy to local anaesthetics Allergy to active substances i fibrin sealant Age below 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fibrin Sealent<br> | Drug: Fibrin sealant<br>* Fibrin sealant is applied on the surfaces of bone and soft tissue of surgery after placement of the prothesis due to the randomised knee.<br>* Other names: Evicel, ATC-kode B02BC30;|
| Placebo Comparator: Saline water<br> | Drug: Saline water<br>* Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | 24 hours postopertive blood loss estimated by drains from each of the knees . | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrin sealant, Prospective randomised double-blind study, Bilateral simultaneous total knee arthroplasty, Blood loss, Postoperative pain, Complications