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

Phase 4

Completed

• Conditions: Blood Loss
• Interventions: Drug: Fibrin sealant; Drug: Saline water

• Registration Number: NCT01472913
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Primary Completion: 2013-08
• Study Completion: 2013-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrin Sealent	Fibrin sealant	-
Saline water	Saline water	-

Primary Outcome Measures

Name	Time	Method
Blood loss	24 hours postoperative	24 hours postopertive blood loss estimated by drains from each of the knees .

Secondary Outcome Measures

Name	Time	Method
swelling	2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day	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.
Pain	2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day.	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.
Range of Movement (ROM)	2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day	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.
Strength	2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day	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.

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark