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

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Blood Loss

Treatments: Drug: Saline water; Drug: Fibrin sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT01472913

H-A-2009-69

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Fibrin Sealent

Active Comparator group

Treatment:

Drug: Fibrin sealant

Saline water

Placebo Comparator group

Treatment:

Drug: Saline water