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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss
• Intervention / Treatment: Drug: Fibrin sealant; Drug: Saline water

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Principal Investigator: Christian Skovgaard Nielsen, M.D, Hvidovre University Hospital; Principal Investigator: Henrik Husted, M.D., Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: October 11, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Complications; Postoperative pain; Blood loss; Fibrin sealant; Prospective randomised double-blind study; Bilateral simultaneous total knee arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: H-A-2009-69