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

Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472913
• Other study ID #: H-A-2009-69
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2011
• Last updated: April 20, 2015
• Start date: August 2010
• Est. completion date: September 2013

Study information

• Verified date: April 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	24 hours postopertive blood loss estimated by drains from each of the knees .	24 hours postoperative	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No