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

Hvidovre University Hospital48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Blood Loss

Interventions

Fibrin sealantDRUG

Fibrin sealant is applied on the surfaces of bone and soft tissue of surgery after placement of the prothesis due to the randomised knee.

Saline waterDRUG

Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hvidovre University Hospital

Hvidovre, Denmark

Outcomes

Primary Outcomes

Blood loss

24 hours postopertive blood loss estimated by drains from each of the knees .

Time frame: 24 hours postoperative

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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